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 Problems Reaction (2414); No Code Available (3191)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, not provided.Lot, udi #: unknown, as lot number was not provided.Expiration date: unknown, as the lot number was not provided.(b)(4).Alternative report identification number a1996003.Manufacturing date: unknown, as the lot number was not provided.Device evaluation: the product was not returned to the manufacturing site for investigation.Therefore, the consumer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records could not be performed as the lot number of the product was not provided.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions and warning for the proper use and handling of the product.Based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported she had an allergic reaction, last wednesday, while using blink and clean lens drops.Reportedly, a physician provided antibiotics for it to calm down.No further information was 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.

• Brand Name: BLINK-N-CLEAN
• Type of Device: REWETTERS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8012215
• MDR Text Key: 125276820
• Report Number: 3004178847-2018-00010
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,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: 10/28/2018
• 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