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 Red Eye(s) (2038); Excessive Tear Production (2235); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Date of event: exact date unknown, information not provided.As the consumer stated, the event occurred a month ago from the time the event was reported, therefore, the best estimate is (b)(6) 2020.(b)(4).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.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.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.

Event Description

A female consumer reported that she used blink revitalens multi-purpose solution with her acuvue 2 soft contact lenses.She felt ¿normal¿ while wearing her contact lenses.However, when she removed her contact lenses both of her eyes became red, watery, and she experienced photophobia.Both eyes were affected.Consumer experienced the reported issue last month.The consumer has not used this brand of multipurpose solution before.The consumer saw her doctor who provided artificial tears and compound tear drops four times a day.At the time of her call to report the event she had not recovered.Symptoms were not improving but had not gotten worse.Consumer reported that her contact lenses are daily wear.She does not rinse/rub her lenses with the solution, and also does not use water to rinse them.She does not sleep, swim, shower or use the hot tub/sauna while wearing them.She hasn¿t had lasik surgery, is not a smoker, and reports no allergies.Through follow-up the consumer stated she used the eye drops from her doctor for 10 days but her eyes are still red.She has not sought further medical assistance, but has went on to purchase compound menthol eye drops and applies them four times a day.No additional 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 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: 10063893
• MDR Text Key: 194795305
• Report Number: 3004178847-2020-00009
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)210611(10)ZE06074
• Combination Product (y/n): Y
• PMA/PMN Number: K093254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2021
• Device Model Number: 09608X
• Device Lot Number: ZE06074
• 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
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACUVUE 2 CONTACT LENSES DAILY WEAR; ACUVUE 2 CONTACT LENSES DAILY WEAR
• Patient Outcome(s): Required Intervention