COMPLETE
Report
- Report Number
- 3004178847-2020-00007
- Event Type
- Injury
- Date Received
- April 17, 2020
- Date of Event
- March 18, 2020
- Report Date
- October 30, 2020
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- LPN
- PMA / PMN Number
- K040839
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
CORRECTED DATA: IN FURTHER REVIEW IT WAS DISCOVERED THAT IN THE INITIAL MEDWATCH REPORT SECTION D4 MODEL NUMBER 9424X WAS PROVIDED. HOWEVER, THIS WAS INCORRECT. THE CORRECT FORMULATION FOR THE REPORTED LOT NUMBER IS 8772X. AS A RESULT OF THE CORRECTED FORMULA AN UPDATE IS ALSO REQUIRED FOR SECTION G5, 510K NUMBER. INITIALLY K014202 WAS PROVIDED, HOWEVER THE APPROPRIATE ENTRY IS K040839. THEREFORE, THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION D4: MODEL: FORMULATION 8772X SECTION G5: 510(K) K040839 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. PLACEHOLDER.
THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.
DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. ALL THE RECORDS FOR PRODUCTION PROCESS WERE FOUND TO BE ACCEPTABLE, ALL TESTING ITEMS WERE COMPLETED AND MET SPECIFICATIONS, INCLUDING INCOMING CHEMICAL MATERIALS TESTING, PRIMARY MATERIALS INSPECTION, PRODUCT PHYSICAL APPEARANCE INSPECTION, BULK AND FINISHED PRODUCT CHEMICAL TESTING AND MICROBIAL TESTING, STERILIZATION RECORDS, ENVIRONMENT MONITORING AND WATER SYSTEM MONITORING. THERE WAS NO NON-CONFORMANCE RELATED TO THIS COMPLAINT. COMPLAINT DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZE06901; ONLY THE OBJECTIVE COMPLAINT WAS REPORTED IN PREVIOUS 12 MONTHS. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.
AGE/ DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
REPORT RECEIVED FROM A PHARMACY REGARDING A CONSUMER¿S EXPERIENCE WITH COMPLETE MULTI-PURPOSE SOLUTION AND ACUVUE 2 SOFT DAILY WEAR CONTACT LENSES. THE CONSUMER FELT UNCOMFORTABLE AFTER WEARING THEIR ACUVUE 2 CONTACTS WHICH WERE RINSED WITH COMPLETE SOLUTION. THE CONSUMER DOUBTED THAT THE SOLUTION CAUSED THE DISCOMFORT. ADDITIONAL INFORMATION WAS PROVIDED, THE CONSUMER STATED THAT SHE IS A NEW USER OF THIS SOLUTION. SHE FELT UNCOMFORTABLE UPON WEARING HER CONTACT LENSES WHICH SHE RINSED WITH SOLUTION ON (B)(6) 2020. THE CONSUMER STATED SHE SOUGHT MEDICAL ATTENTION AND COMPLAINED ABOUT HER CONTACT LENSES. THE PHYSICIAN PRESCRIBED THE FOLLOWING, TRIVITAMINS B TABLETS, GATIFLOXACIN EYE GEL, VITAMIN A PALMITATE EYE GEL. 3 TIMES PER DAY/2 PILLS PER TIME; 3 TIMES PER DAY/ 0.10G PER TIME; 3 TIMES PER DAY. THE CONSUMER¿S LAST EYE EXAM WAS (B)(6) 2020. THE PATIENT STATED HER EYES STILL FEEL DRY. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438200 | COMPLETE | SOLUTIONS | LPN | JOHNSON & JOHNSON SURGICAL VISION, INC. | 8772X | ZE06901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ACUVUE 2 CONTACT LENSES| ACUVUE 2 CONTACT LENSES |