MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. BLINK-N-CLEAN; REWETTERS

Model Number	08772X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Irritation (1941); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Date of event: exact date unknown, information not provided.Best estimate is between (b)(6) 2019.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no complaint was reported in the previous 12 months.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Consumer reported that she purchased blink and clean lens drops around (b)(6) but upon using the drops she experienced irritation, tingling and bumps.She stopped using the drops and the symptoms abated.Her doctor prescribed antibiotics and blink lubricating drops for her dry eye and to provide immediate comfort.She tried the blink and clean lens drops again yesterday ((b)(6) 2020) and experienced the same thing plus irritation on the eye lid and the skin around the eye.Her eyes feel better but are still tender.Thru additional follow-up the consumer reiterated that her eyes feel better although there is still discomfort.Additionally, she reported that her eyes are sensitive to ¿screens¿ and light.No further information was provided.
Additional Manufacturer Narrative
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.

• Brand Name: BLINK-N-CLEAN
• Common Device Name: REWETTERS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9628992
• Report Number: 3004178847-2020-00003
• Device Sequence Number: 10851206
• Product Code: LPN
• UDI-Device Identifier: 30827444000127
• UDI-Public: (01)30827444000127(17)200504(10)ZD05433
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P850088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/04/2020
• Device Model Number: 08772X
• Device Lot Number: ZD05433
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005