MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ALLERGAN CUP (GORTEX); ACCESSORIES

Model Number AGNCG

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional information: age/date of birth: unknown, information not provided.Date of event: unknown, information not provided.The lot number provided is for the kit.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a consumer complained that she had been using concept 1-step with her husband, but both of their contact cases dedicated to the product had gotten moldy in the bottom.They usually wash their cases with tap water, and let them dry naturally, but sometimes the cases did not completely dry by the next time of taking care of their lenses.There was no patient injury.No further information was provided.This report is for the male consumer.A separate report will be filed for the female consumer.

Manufacturer Narrative

Device evaluation: no product evaluation was performed as the consumer discarded the lens case.Manufacturing record review: reported lot number zh04871 was a kit lot.Its filling lot ze04868 and compounding lot ze04866 were manufactured in march 2020.All the records for production process were found to be acceptable, all testing items were completed and met specifications, including incoming chemical materials testing, primary materials inspection, product physical appearance inspection, bulk and finished product chemical testing and microbial testing, sterilization records, environment monitoring and water system monitoring.There was no non-conformance related to this complaint.A review of complaints for the previous 12 months by the reported lot number: zh04871 revealed 4 total complaints, however, only the objective complaint was reported for the similar issue.Conclusion: based on manufacturing record review and historical complaint review, there was no indication of a product malfunction.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.At the time of this report has been submitted.

• Brand Name: ALLERGAN CUP (GORTEX)
• Type of Device: ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10688355
• MDR Text Key: 211653037
• Report Number: 3004178847-2020-00025
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 14987617002012
• UDI-Public: (01)14987617002012(17)211231(10)ZH04871
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: AGNCG
• Device Lot Number: ZH04871
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT# ZH04869, TABLET LOT# 84485; SOLUTION LOT# ZH04869, TABLET LOT# 84485