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

Model Number 08772X

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

Patient Problem Dry Eye(s) (1814)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Lot#: unknown, information not provided.Expiration date: unknown as the lot# was not provided.Unique identifier: udi# is unknown as the lot# was not provided.Device manufactured date: unknown as the lot# was not provided.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/serial number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that after using blink-n-clean lens drops on (b)(6) 2020 she experienced dry eyes in both eyes.The consumer sought medical attention and was prescribed hylo forte eye drops.No culture or other type of test was performed by the doctor.The symptoms abated after using the eye drops.The patient stated that her eyes are fine now.The product is not available to be returned.The consumer used two different bottles and reported not knowing which one caused the issue.Therefore, a separate report is being submitted for each bottle.This report is two of two.

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
• Type of Device: REWETTERS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10383093
• MDR Text Key: 202181724
• Report Number: 3004178847-2020-00019
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 08772X
• 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