ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
Report
- Report Number
- 1119421-2024-01775
- Event Type
- Injury
- Date Received
- September 10, 2024
- Report Date
- March 12, 2026
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652422840
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION WAS PROVIDED IN B5 AND H6. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (DFT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION WAS PROVIDED IN B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION WAS PROVIDED IN A.2., B.5., D.4. AND D.6.A. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
PATIENT QUALITY OF LIFE HAS BEEN AFFECTED, DUSK, DAWN, SHADOWED AREA VISION MAKES DRIVING AND EVERYDAY LIVING CHALLENGING AND AT TIMES DANGEROUS. ANY OF THE OPTIONS SO FAR THAT HAVE BEEN PROVIDED TO ME DO NOT AND WILL NOT FIX THE NIGHT BLINDNESS.
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT¿S VISION WAS NOT CLEAR. ABOUT A WEEK AFTER VISION IS NOT GOOD AT ALL, PATIENT WAS ADVISED IT MIGHT TAKE LONGER AND WAS TOLD TO WAIT THREE MONTHS AND AT WHICH TIME YAG LASER PROCEDURE COULD BE PERFORMED TO FIX THE PROBLEM. WRINKLING OF THE POSTERIOR CAPSULE WAS LIKELY THE ISSUE. ONE WEEK AFTER YAG LASER PROCEDURE, PATIENT¿S VISION WAS STILL NOT CLEAR, AND PATIENT CANNOT DRIVE. PATIENT¿S VISION IS EVEN MORE IMPAIRED IN LOW LIGHT AND SIMPLY TERRIBLE AT NIGHT WITH ALL LIGHTS BEING LARGE HALOS. DOCTOR TOLD TO WAIT TWO TO SIX WEEKS TO ADJUST AND HEAL FROM THE YAG. PATIENT USED THE RECOMMENDED STEROID FOR EYES AND LUBRICANT. THREE WEEKS LATER STILL DID NOT IMPROVED VISION AND HAD MORE PROBLEMS SEEING. POSTERIOR CAPSULATION HAD BEEN PERFORMED. THIS REPORT IS ASSOCIATED WITH TWO COMPLAINTS. THIS FILE IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT WAS FRUSTRATED WITH VISION AND THE LOST QUALITY OF LIFE.
ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT COMPLETED TESTS AT THE NEURO-OPHTHALMOLOGIST AND THEY FOUND NOTHING WRONG WITH EYES THAT COULD OR WOULD CONTRIBUTE TO THE PROBLEMS. THE END RESULT WAS THAT MULTIFOCAL LENSES WERE NOT DOING WHAT IT WAS SUPPOSED TO, AND THIS WAS CAUSE OF THE PROBLEM. THE PATIENT WAS DISSATISFIED WITH PRODUCT.
ADDITIONAL INFORMATION RECEIVED STATING THAT, PATIENT CONTACTED DOCTOR¿S OFFICE AND DOCTOR HAS NOT GOTTEN BACK TO PATIENT AT THIS TIME. PATIENT STATED HE UNDERSTAND THAT GLASSES MAY HAVE BEEN REQUIRED FOR REASONS OF CLARITY OR READING, HOWEVER AS PATIENT STATED BEFORE IF, HE WAS IN OUTDOORS ON A SUNNY DAY VISION IS NEAR PERFECT, HE CAN READ SUFFICIENTLY WITHOUT GLASSES AND ONLY REQUIRE READERS FOR DOING UP CLOSE FINER DETAIL THINGS. PATIENT¿S ISSUE WAS ONCE IT BECOMES OVERCAST OR SLIGHTLY SHADED CLARITY OF VISION WAS DIMINISHED TO A POINT WHERE LONG DISTANCE IS TOTALLY DISTORTED AND ALL LIGHTS APPEAR WITH HALOS. DOCTOR SAYS PATIENT HAVE 20/20 VISION WHICH ON A SUNNY DAY, HE WAS PROBABLY CORRECT IN SAYING, BUT PATIENT NOT ABLE TO SEE PROPERLY IN LOW LIGHT OR NIGHTTIME. DOCTOR STATED THE PATIENT HAD VISUALLY SIGNIFICANT CATARACTS AND DESIRED SPECTACLE INDEPENDENCE POST OPERATIVELY. DOCTORS DISCUSSED PATIENT OPTIONS AND SELECTED COMPANY TORIC EXTENDED RANGE INTRAOCULAR LENSES TO BE PLACED UNDER ORA INTRAOPERATIVE BIOMETRY. PATIENT WAS FOUND TO BE 20/20 OS UNCORRECTED IN HIS INITIAL POST OPERATIVE VISIT AT APPROXIMATELY 14 DAYS. PATIENT FELT HE DID NOT SEE WELL IN DIM LIGHT AND DID NOT LIKE THE READING DISTANCE HE NEEDED TO USE WITH THE COMPANY INTRAOCULAR LENSES, ALTHOUGH THIS WAS DISCUSSED WITH HIM PRIOR TO HIS SURGICAL MANAGEMENT. PATIENT STATED THAT HE HAS DIFFICULTY DRIVING AND HIS VISION WAS NOT OF THE QUALITY THAT HE WAS HOPING FOR. DOCTOR REVIEWED HIM AT 3 MONTHS POST OPERATIVELY AND HE HAD EARLY POSTERIOR CAPSULAR OPACIFICATION WITH WRINKLING AND PERFORMED A YAG CAPSULOTOMY. THIS DID NOT RESULT IN ANY SIGNIFICANT CHANGE IN VISION. THEN REFERRED PATIENT TO NEURO-OPHTHALMOLOGIST, AS DOCTOR COULD SEE NO UNDERLYING CAUSE FOR HIS DISAPPOINTMENT IN THE SURGERY. PATIENT REMAINS WITH UNCORRECTED VISUAL ACUITY OF 20/25 OD AND 20/20 OS. HE IS NOT HAPPY WITH THIS. ASIDE FROM THE PATIENT'S DISSATISFACTION, HIS SURGERY WAS UNEVENTFUL AND THERE WERE NO POST OPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445495 | ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL | INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | DFT215 | 15320713 | 00380652422840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention| O | EFFEXOR XR 150 MG.| ROSUVASTATIN 10 MG.| VENLAFAXINE 75 MG. |