ACUVUE OASYS
Report
- Report Number
- 1057985-2017-00082
- Event Type
- Injury
- Date Received
- July 7, 2017
- Date of Event
- June 16, 2012
- Report Date
- August 17, 2017
- Manufacturer
- JOHNSON & JOHNSON VISION CARE, INC. ¿ US
- Product Code
- LPM
- PMA / PMN Number
- P040045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ON (B)(6) 2017 THE PATIENT (PT) SENT MEDICAL RECORDS BY EMAIL TO THE AFFILIATE IN THE (B)(6). THE FOLLOWING NEW MEDICAL INFORMATION WAS PROVIDED: (B)(6) 2013: OPHTHALMOLOGY NOTE REFERRAL: PLS SEE PT FOR 2ND OPINION; PT TREATED FOR LAST 3-4 MONTHS WITH NO APPARENT RESOLUTION; PT PRESENTED AT END OF DEC LAST YEAR WITH KERATITIS; PT HAD A RING SHAPED INFILTRATE AND I SUSPECTED ACANTHAMOEBA, ALTHOUGH CULTURES WERE NEGATIVE; PRESENT PT IS CONTINUED ON PROPAMIDINE QID; G PHMB QID; MOXIFLOXACIN TID; AND GANCYCLOVIR GEL BID; WITH FML TID; THERE IS VERY LITTLE ACTIVITY IN THE CORNEA, ALTHOUGH THERE IS STILL A RING SHAPED LESION QUITE POSSIBLE NOAH¿S SCAR IN THE CORNEA; THE VISION FLUCTUATES QUITE SIGNIFICANTLY; TODAY WITH REFRACTION WAS 6/24 PH VISION WAS 6/18 AND HAS BEEN AS GOOD AS 6/12. (B)(6) 2013: 1ST APPOINTMENT AT LEICESTER ROYAL INFIRMARY. R VA 0.84, PH 0.56. NOTED AS AN ACUVUE LENS WEARER, 2 WEEKLY, CLEANING WITH AO SEPT SOLUTION VERY DILIGENTLY. AK EPISODE STARTED (B)(6) 2013. BIOPSY TAKEN. PX IN QUITE A LOT OF PAIN. (B)(6) 2013: REVIEW APPOINTMENT . NO BIOPSY RESULTS RECEIVED, THEREFORE ANOTHER BIOPSY TAKEN . R VA 6/36, PH 6/18. (B)(6) 2013: CONSULT OPHTHALMOLOGIST. DIAGNOSIS: RIGHT EYE CONTACT LENS KERATITIS. VA: RIGHT EYE 6/60 IMPROVING TO 6/18 WITH PINHOLE. COMMENT: REFERRAL: PT IS CL WEARER; C/O SORE EYES IN NOV/DEC AND WAS SEEN AT HOSPITAL; POSSIBLE ACANTHAMOEBA KERATITIS AND HAS BEEN ON TREATMENT SINCE (B)(6). PT HAD CONE BIOPSY AND SENT TO PATHOLOGY; HAVE REPEATED CORNEAL BIOPSY 3 DAYS AGO AND SENT FOR PCR, MICROBIOLOGY, HISTOPATHOLOGY ALSO; NO GROWTH AFTER 2 DAYS; RIGHT EYE EPITHELIAL DEFECT ALL ROUND THE CORNEAL BIOPSY IS SLOWLY HEALING; PT DOES HAVE STROMAL RING INFILTRATE; NO INTRAOCULAR INFLAMMATION; IOP WITHIN NORMAL LIMITS; AGREE THAT RIGHT EYE BEHAVED LIKE ACANTHAMOEBA KERATITIS; OTHER POTENTIAL DIAGNOSIS IS FUNGAL KERATITIS; PT TO CONTINUE TREATMENT AND RETURN IN 3 DAYS; TREATMENT: TREATMENT: GUTTAE PHMB EVERY HOUR; G CHLORAHEHADINE EVERY HOUR; G DEXAMETHASONE QDS RIGHT EYE; G LEVOFLOXACIN 6 TIMES A DAY; G CYCLOPENTOLATE 1 % BD RIGHT EYE; WILL REVIEW NEXT WEEK (B)(6) 2013: OPHTHALMOLOGY: PT HAD F/U FOR 2ND BIOPSY; PT STATES RIGHT EYE FEELS MUCH BETTER; SLIGHTLY UNCOMFORTABLE WITH A FBS AND SLIGHT PHOTOPHOBIC; VA: 6/18 RIGHT EYE CORRECTED WITH PINHOLE; FUNGAL PCR HAS NOT SHOWN FUNGUS; HISTOPATHOLOGY HAVE STATED INSUFFICIENT MATERIAL; NO GROWTH ON CULTURE AND NO GROWTH OF ACANTHAMOEBA; CURRENTLY TAKING POLYHEXADINE 0.02% HOURLY; CHLORHEXADINE TWO-HOURLY; DEXAMETHASONE 6 TIMES DAY; LEVOFLOXACIN 6 TIMES DAILY; CYCLOPENTOLATE BID; AND BETNESOL OINTMENT AT HS; TODAY THERE IS SLIGHT IMPROVEMENT OF STROMAL INFILTRATE BUT SLOW WOUND HEALING WHERE BIOPSY WAS TAKEN; THE A/C IS QUIET AND PRESSURE WAS NORMAL; STOP CHLORHEXIDINE BUT CONTINUE WITH POLYHEXADINE 6 TIMES DAY; DEXAMETHASONE QID; LEVOFLOXACIN 6 TIMES DAY; CYCLOPENTOLATE BID AND BETNESOL AT HS. (B)(6) 2013: CL KERATITIS. EYE FEELS A LITTLE BETTER, STILL UNCOMFORTABLE FB SENSATION, PHOTOPHOBIC. VA 6/36, PH 6/18. BIOPSY RESULTS: NO FUNGUS DETECTED, NO GROWTH ON CULTURE, NO ACANTHAMOEBA. TREATMENT WITH PHMB, DEX, LENO, CYCLO AND BETNESOL DRAWING DEPICTS: EPITHELIAL DEFECT (PREV BIOPSY); CLOUDY INFILTRATE; UPTAKE STAIN; A/C QUIET. (B)(6) 2013: OPHTHALMOLOGY NOTE: DIAGNOSIS: RIGHT EYE CONTACT LENS KERATITIS ¿ PRESUMED ACANTHAMOEBA. UPDATE; REPEAT RIGHT EYE BIOPSY WAS NEGATIVE; HOWEVER, PT HAS GOOD RESPONSE TO TREATMENT; VA OD: 6/60, DUE TO STROMAL HAZE, EPITHELIAL DEFECT ALMOST HEALED; RING INFILTRATE IS SIGNIFICANTLY BETTER, LEAVING A CENTRAL STROMAL HAZE AND A RING SCAR; NO INTRAOCULAR INFLAMMATION AND IOP ARE WNL; TREATMENT: DEXAMETHASONE QDS; LEVOFLOXACIN QDS; CYCLOPENTOLATE BD; G PHMB 6 TIMES DAY; AND BETNESOL AT HS; REVIEW: 2 WEEKS. (B)(6) 2013: CONSULT OPHTHALMOLOGIST: DIAGNOSIS: RIGHT EYE CONTACT LENS KERATITIS ¿ PRESUMED ACANTHAMOEBA. JUST TO UPDATE ¿ PT HAD A SUSPICION OF RIGHT EYE ACANTHAMOEBA/KERATITIS. REPET CORNEAL BIOPSY WAS NEGATIVE. PT HAS GOOD RESPONSE TO TREATMENT. VA IN RIGHT EYE IS ABOUT 6/60, DUE TO STROMAL HAZE, EPITHELIAL DEFECT HAS ALMOST COMPLETELY HEALED. THE RING INFILTRATE IS SIGNIFICANTLY BETTER, LEAVING BEHIND A CENTRAL STROMAL HAZE AND A RING SCAR. THERE IS NO INTRAOCULAR INFLAMMATION AND IOP ARE WITHIN NORMAL LIMITS. PT WAS ADVISED TO CONTINUE TREATMENT AND RETURN IN 2 WEEKS. TREATMENT: G PHMB 6 TIMES DAILY; G DEXAMETHASONE QDS RIGHT EYE; G LEVOFLOXACIN QDS RIGHT EYE; G CYCLOPENTOLATE 1% BD RIGHT EYE; OC BETNESOL NOCTE RIGHT EYE. (B)(6) 2013: OPHTHALMOLOGY NOTE. PT HAD BIOPSY LAST MONTH, NEVER GREW ANYTHING; CURRENT TREATMENT INCLUDES PHMB, DEXAMETHASONE, LEVOFLOXACIN, CYCLOPENTOLATE, BETNESOL; UNFORTUNATELY PT DESCRIBED AN INCREASE IN DISCOMFORT AND REDUCTION IN VISION; VA: 0.8 OD; SLIGHTLY INJECTED AND DOES HAVE QUITE MARKED STROMAL EDEMA AROUND PRECIOUS CORNEAL BIOPSY SITE; + NEUROEPITHELIAL DEFECT NASALLY; A/C ¿ CLEAR; HAVE INCREASED DEXAMETHASONE EVERY 2 HOURS AND WILL SEE PT AGAIN IN 1 WEEK. (B)(6) 2013: CLK - ? ACANTHAMOEBA. FUNGAL PCR. NO GROWTH/ ACANTHAMOEBA CULTURE OF BIOPSY (B)(6) 2013. TREATMENT: PHMB X 6; DEX X 4; LENO X 4; CYCLO X 2; BETNESOL X 2. FEELS THINGS HAVE DETERIORATED. DECREASE LENS X 2; INCREASE DEX 2. (B)(6) 2013: OPHTHALMOLOGY NOTE: DIAGNOSIS: OD PRESUMED ACANTHAMOEBA - CULTURE (B)(6). VA: LOGMAR 1. PT IS STILL QUITE SYMPTOMATIC WITH A SORE EYE; KERATITIS IS SLIGHTLY WORSE IN TERMS OF NEW EPITHELIAL DEFECTS AND AREA OF THINNING; COULD PROBABLY BE A REACTIVATION OF THE KERATITIS; CORNEAL SCRAPES WERE DONE TODAY AND TREATMENT CHANGED; TREATMENT: G PHMB Q2 H; CHLORHEXADINE Q2 H; DEXAMETHASONE QDS; LEVOFLOXACIN BD; CYCLOPENTOLATE BD; BETNESOL NOCTE; REVIEW 2 DAYS. (B)(6) 2013: SPECIMEN COLLECTED; 12/09/13 ¿ SPECIMEN RECEIVED. SPECIMEN COMMENTS: RAPID MRSA SCREEN; METHICILLIN RES. STAPH AUREUS NOT ISOLATED. OPHTHALMOLOGY NOTE: RIGHT KERATITIS HAS REMAINED STABLE AND RECENT CORNEAL SCRAPES ARE NEGATIVE; DISCUSSED WITH PT THAT WE DO NOT HAVE A POSITIVE DIAGNOSIS IN SPITE OF 3 BIOPSIES; SUGGESTED WE DO A PENETRATING CORNEAL TRANSPLANT; TREATMENT: G PHMB EVERY 2 HOURS; G DEXAMETHASONE QDS; G LEVOFLOXACIN 6 TIMES A DAY; G CYCLOPENTOLATE 1% BD RIGHT EYE NOCTE; G CHLORHEXIDINE EVERY 2 HOURS. (B)(6) 2013: THERAPEUTIC PK. (B)(6) 2013: CLEAN GRAFT. PX MORE COMFORTABLE; FEELS VERY WELL. HAS HAD DROPS YESTERDAY AND TODAY. DUE FOR F/U 25/09/2013. HOME TODAY; KEEP FU APPOINTMENT. (B)(6) 2013: PATHOLOGY REPORT: RIGHT CORNEAL BUTTON: CONCLUSION: RIGHT CORNEA: ACANTHAMOEBA KERATITIS. (B)(6) 2013: 5 DAYS POST GRAFT. EYE FEELING MORE COMFORTABLE THAN PREVIOUS WEEKS. VISION R 1.0, PH 0.9. CLEAR GRAFT . TREATMENT: DEX 3; PHMB 3; CYCLO;. (B)(6) 2013: RIGHT SUSPICIOUS ACANTHAMOEBA KERATITIS. R VA 6/60, PH 6/18-1. CURRENT TX: DEX, PHMB, CYCLO. EYE COMFORTABLE. CONTINUE SAME TREATMENT. (B)(6) 2013: CLINICAL DATE: CLINICAL CONSULT OPHTHALMOLOGY NOTE. DIAGNOSIS: RIGHT PRESUMED ACANTHAMOEBA KERATITIS. PT WAS REVIEWED IN MY CLINIC A FEW DAYS AGO WHEN THE RIGHT EYE WAS SORER WITH EPITHELIAL DEFECTS. THIS ALMOST LOOKED LIKE A RECURRENCE OF KERATITIS. CORNEAL SCRAPES WERE DONE, WHICH ARE NEGATIVE AFTER 48 HOURS. TODAY PT SEEMS COMFORTABLE AND HAVE ADVISED PT OF THE FOLLOWING TREATMENT. TREATMENT: G LEVOFLOXACIN 6 TIMES DAILY; G PHMB Q 2 HOURS; G CHLORHEXIDINE Q 2 HOURS; G DEXAMETHASONE MINIMS QDS RIGHT EYE; G CYCLOPENTOLATE 1 % MINIMS BD; OC BETNESOL NOCTE. REVIEW: ONE WEEK. (B)(6) 2013: OPHTHALMOLOGY NOTE: ACANTHAMOEBA KERATITIS W/ PENETRATING THERAPEUTIC PK (B)(6) 2013. PT FEELING VERY COMFORTABLE AND VISION IS IMPROVING. VA CORRECTED WITH PINHOLE WAS 0.3 AND THE EYE WAS WHITE AND THE GRAFT IS LOOKING VERY HEALTHY. HAPPY WITH RESULT OF KERATOPLASTY. TREATMENT: DEX; PHMB; CYCLO . REVIEW: 3 WEEKS. (B)(6) 2013: OPHTHALMOLOGY NOTE: VA: 6/60, IMPROVING TO 6/12 WITH PINHOLE. PTS CORNEAL TRANSPLANT WAS CLEAR WITH NO CLINICAL EVIDENCE OF A RECURRENCE OF HER ACANTHAMOEBA KERATITIS; TREATMENT: DEXAMETHASONE QDS; PHMB QDS; CHLORHEXIDINE QDS; REVIEW: 3 WEEKS. (B)(6) 2013: COMFORTABLE. TREATMENT: DEX; PHMB. DECREASE PHMB AND DEX X 3. (B)(6) 2014: 6/12 MONTHS POST THERAPEUTIC PK FOR ACANTHAMOEBA KERATITIS. VA: 6/60 ¿ PH. CLEAR GRAFT. CONSIDER STOPPING PHMB NEXT VISIT. (B)(6) 2014: OPHTHALMOLOGY NOTE: OD ACANTHAMOEBA KERATITIS. OD PENETRATING CORNEAL TRANSPLANT. PT HAS A FEW RIGHT SUTURES WHICH WERE REMOVED. DEVELOPING A SIGNIFICANT CATARACT AND WILL NEED CATARACT SURGERY IN THE NEAR FUTURE. IOP: BORDERLINE AND 19 MMHG. TREATMENT: CHLORHEXADINE TDS; VEXOL TDS; CHLORAMPENICOL ONE WEEK. REVIEW: 6 WEEKS. (B)(6) 2014: PH ¿ NO IMPROVEMENT. NOTES ILLEGIBLE ¿ HANDWRITTEN DR. NOTES. (B)(6) 2014: OPHTHALMOLOGY NOTES: CORNEAL GRAFT LOOKING CLEAR ALTHOUGH PT DEVELOPED DENSE WHITE CATARACT; DISCUSSED WITH PT WHO WANTS CATARACT REMOVAL. (B)(6) 2014: VISION R HM NO IMPROVEMENT. ACANTHAMOEBA KERATITIS. THERAPEUTIC PK ¿ (B)(6) 2013. DEEP/QUIET AC. POST PK CATARACT ¿ DENSE. (B)(6) 2014: HAND MOVEMENTS IN OD. THERAPEUTIC PK ¿ (B)(6) 2013. RIGHT DENSE CATARACT. PLAN: PT LISTED FOR OD CATARACT EXTRACTION PLUS A LENS IMPLANTATION. (B)(6) 2014: R PHACO + IOL. (B)(6) 2014: PH NO IMPROVEMENT. (B)(6) 2014 R PHACO + IOL. PREVIOUS PK GRAFT FOR AK. AC ¿ DEEP/QUIET. CLEAR GRAFT. PT ¿DELIGHTFUL¿ WITH RESULTS. TREATMENT: DEXA; CHLORAHEX; CYCL. (B)(6) 2014: OPHTHALMOLOGY NOTE: R VISION 6/18, PH 6/12, VA 6/6-1 PT DOING WELL AFTER RECENT CATARACT OPERATION. TREATMENT: VEXOL TDS; CHLORHEDADINE TDS. (B)(6) 2014: OPHTHALMOLOGY NOTE: OD THERAPEUTIC CORNEAL GRAFT, RIGHT CATARACT EXTRACTION. PT REMAINS COMFORTABLE FOLLOWING SURGICAL PROCEDURES. VA 6/6 AND THE CORNEA IS LOOKING BETTER. TREATMENT: VEXOL TDS; CHLORHEXADINE TDS. REVIEW: 2 MONTHS. (B)(6) 2014: VA - NO IMPROVEMENT. POST THERAPEUTIC PK/CATARACT EXT. MILD SUB INJ HEMORRHAGES. ADD S. HYLO TEARS PRN. KEEP NEXT APPOINTMENT. (B)(6) 2015: R VA 6/9 AND QUIET. GRAFT CLEAR. SUTURES INTACT. IRIS ATROPHY. IN VIEW OF GOOD VA, LEAVE SUTURES IN SITU; STOP CHLORAH; DECREASE VEXOL TO QD; CONTINUE HYLO TEARS. (B)(6) 2015: OPHTHALMOLOGY NOTE: PT REVIEWED TODAY, OD CORNEAL GRAFT IS CLEAR AND COMPACT AND PT HAS VA 6/6 OD. TREATMENT: VEXOL QD; HYLO TEARS PRN. REVIEW: 3 MONTHS. (B)(6) 2015: TX: CHLORAHEXADINE BID; VEXOL BID. GRAFT CLEAR. PLAN: CONTINUE SAME TREATMENT. (B)(6) 2016: CORNEAL GRAFT DUE TO ACANTHAMOEBA KERATITIS ¿ (B)(6) 2013. PHACO + IOL (B)(6) 2014. PHACO + IOL (B)(6) 2016. RX: VEXOL OD. BROKEN SUTURE REMOVAL. PLAN: START LOTEMAX; LEVOFLOXACIN QID; TOPOGRAPHY TODAY. (B)(6) 2016: BROKEN SUTURE. ATTEMPT TO REMOVE HALF BROKEN SUTURE ¿ NOT EXPOSED. GRAFT CLEAR. PLAN: CHLORAX; LOTEMAX. (B)(6) 2016: VERY HAPPY. EYE COMFORTABLE W/LOTEMAX. FEW INTACT SUTURES. SOME SUTURE REMOVALS. PLAN: LOTEMAX OD. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS. (B)(4).
(B)(4). (B)(6).
ON 15JUN2017 AN EMAIL WAS RECEIVED FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) REFERENCE # 2017/005/019/401/008 ADVISING THAT A PATIENT (PT) IN THE UNITED KINGDOM REPORTED ¿MYSELF SUFFERED ACANTHAMOEBA KERATITIS¿ ON (B)(6) 2012 WHILE WEARING AN ACUVUE BRAND CONTACT LENS. ON 22JUN2017 A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS OBTAINED: THE PT REPORTED HE/SHE WOULD E-MAIL WITH A REPORT OF THE INCIDENT MADE AT THE TIME OF THE EVENT; PT COULDN¿T RECALL THE DETAILS AND WAS NOT AT HOME TO REVIEW RECORDS. THE LOT NUMBER AND THE SUSPECT PRODUCT WERE NOT AVAILABLE, BUT THE PT REPORTED USING ACUVUE OASYS BRAND CONTACT LENSES AT THE TIME OF THE EVENT. PT REPORTS A TWO-WEEK REPLACEMENT SCHEDULE AND WORE THE LENSES SEVEN DAYS A WEEK FOR APPROXIMATELY FOURTEEN HOURS A DAY. THE PT REPORTS NO SWIMMING, SLEEPING, OR SHOWERING IN THE LENSES WITH A TWO-STEP CLEANING PROCESS ENSURING A RUB AND RINSE OF THE LENSES; PT ALSO REPORTS THE CONTACT LENS CASE WAS CHANGED REGULARLY. ON (B)(6) 2017 AN EMAIL WAS RECEIVED WITH ADDITIONAL INFORMATION: THE PT REPORTED THAT IN (B)(6) 2012 HIS/HER RIGHT EYE BECAME IRRITATED AND SORE. THE PT REPORTS TAKING THE SUSPECT RIGHT EYE LENS OUT, BUT THE SYMPTOMS CONTINUED. THE FOLLOWING DAY (DATE OF THE EVENT WAS NOT REPORTED) HE/SHE WENT TO THE CHEMIST AND WAS GIVEN DROPS (MEDICATION NAME AND FREQUENCY USED WERE NOT REPORTED). ABOUT A WEEK LATER THE SYMPTOMS RETURNED AND THE PT WENT TO THE CHEMIST REPORTING ¿IT FELT LIKE A PIECE OF WOOD IN MY EYE¿. THE CHEMIST GAVE THE PT EYE DROPS AND ADVISED THE PT TO GO TO HIS/HER OPTICIAN. THE PT STATED THAT AFTER A COUPLE OF DAYS THE PAIN WAS ¿BECOMING MORE INTENSE¿ AND THE PT WENT TO THE OPTICIAN FOR AN EVALUATION. THE OPTICIAN ADVISED THE PT TO GO TO THE HOSPITAL AND TELL THE DOCTORS THAT HE/SHE HAD ¿A CONTACT LENSE INFECTION.¿ THE PT REPORTED BEING TREATED FOR ¿MANY DIFFERENT DISORDERS, INCLUDING HERPES¿ (DATES WERE NOT REPORTED). THE PT REPORTED THAT THE ¿PAIN DUE TO THE PHOTOPHOBIA AND AK WAS EXCRUCIATING.¿ THE PT WAS TRANSFERRED TO ANOTHER EYE CARE PROVIDER (ECP) AND HAD ¿SCRAPES¿ TAKEN FROM THE EYE, BUT THE RESULTS WERE NEGATIVE. THE PT REPORTS EYE PAIN AND A LOSS OF VISION. THE PT REPORTED THAT A BIOPSY WAS ALSO COMPLETED, BUT THE BIOPSY RESULTS WERE NEGATIVE. IN EARLY (B)(6) THE PT WAS REFERRED TO ANOTHER ECP WHO SPECIALIZED IN ACANTHAMOEBA WHO PERFORMED A BIOPSY (BIOPSY RESULTS WERE NOT REPORTED).¿ IN (B)(6) 2013, THE ECP SUGGESTED A CORNEA TRANSPLANT. THE PT REPORTED THAT THE CORNEA TRANSPLANT WAS COMPLETED (DATE OF THE PROCEDURE WAS NOT REPORTED). THE PT REPORTED THE PAIN WAS GONE AND HE/SHE COULD SEE AFTER THE CORNEAL TRANSPLANT. THE PT REPORTED THAT HIS/HER EYESIGHT WAS ¿SHORT-LIVED¿ AS A CATARACT FORMED IN THE TRANSPLANTED EYE. IN (B)(6) 2014 THE CATARACT WAS REMOVED. IN (B)(6) 2015, THE ECP GAVE THE PT A PRESCRIPTION LENSE FOR THE NON-TRANSPLANT EYE TO ¿EQUAL THEM UP¿. THE PT ALSO REPORTED THAT HE/SHE HAD ¿A SLIGHT CATARACT REMOVED AT THE SAME TIME.¿ THE PT ALSO REPORTED HAVING SEVERAL LOOSE STITCHES REMOVED WITH ANTIBIOTIC GIVEN POST PROCEDURE TO PREVENT ANY INFECTION. THE PT REPORTED THE USE OF LOTEMAX FOR ANTI-REJECTION AND A LUBRICATING EYE DROP TO COMBAT DRY EYE. ECP VISITS ARE COMPLETED TO ENSURE BLOOD VESSELS DO NOT GROW INTO THE CORNEA. THE PTS MEDICAL RECORDS WERE REQUESTED FOR REVIEW, BUT NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474870 | ACUVUE OASYS | LENSES, SOFT CONTACT, EXTENDED WEAR | LPM | JOHNSON & JOHNSON VISION CARE, INC. ¿ US | NA | UNK-PH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |