MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. BLINK REVITALENS; SOLUTIONS

Model Number 09608X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Date of event: unknown, information not provided.Lot number: unknown, information not provided.Expiration date: unknown, information not provided.Unique identifier: udi# is unknown as the lot# was not provided.Device manufacture date: unknown, as lot number not provided.Device evaluation: product testing could not be performed as the product was not returned.The consumer¿s reported event could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Complaint data was trended in previous 12 months by the product family formula: 9608x search result: total two(2) complaints were reported for the same/similar issue in previous 12 months.No product deficiency was identified in either case.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A female consumer initially reported that she used (b)(6) contact lens solution and experienced a severe allergic reaction.Through follow-up it was learned the patient used the solution 11 times, once every night to disinfect and store her contact lenses.She reported being examined by her optometrist (od) who diagnosed her with severe allergic reaction in both eyes, and an infection in her left eye as a result of the solution.She was prescribed tobramycin and dexamethasone four drops a day for seven days.The bottle used was a sample provided by the od who kept the product.The unit is not available for return.No additional information provided.

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.

Manufacturer Narrative

Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Complaint data was trended in previous 12 months by the product family with the criteria: manufacturing site: amo hangzhou; formula: 9608x; reported patient code: infection eye.Search result: only the objective complaint was reported for the same/similar issue in previous 12 months.Complaint data was trended in previous 12 months by the product family with the criteria: manufacturing site: amo hangzhou; formula: 9608x; reported patient code: irritation.Search result: total 22 complaints were reported for the same/similar issue in previous 12 months.No product deficiency was identified among them.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: BLINK REVITALENS
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9767076
• MDR Text Key: 192680688
• Report Number: 3004178847-2020-00005
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K093254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 09608X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention