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 female consumer.A separate report will be filed for the male consumer.

Manufacturer Narrative

Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 11/3/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: microbiological testing was not required since no infection to the customer was reported.By checking the returned oxycup, there were contaminations of black mold observed on the cap.Per initial report provided by the customer, the oxycup was washed using tap water which may contaminate the oxycup.Manufacturing record review: reported lot number zh04569 was a kit lot.Its filling lot zh04567 and compounding lot zh04566 were manufactured in mar 2020.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.In conclusion, reported lot was deemed acceptable for release per material and products releasing management.Complaint data was trended in previous 12 months by the reported lot number: zh04569; search result: total three complaints were reported for the same lot in previous 12 months.No product defect was identified.Conclusion: based on the manufacturing record review and historical complaint review, there is no indication of a malfunction or product quality deficiency.No escalation is required.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: 10688342
• MDR Text Key: 211649996
• Report Number: 3004178847-2020-00024
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 14987617002012
• UDI-Public: (01)14987617002012(17)211130(10)ZH04569
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: AGNCG
• Device Lot Number: ZH04569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT# ZH04568, TABLET LOT# 84485; SOLUTION LOT# ZH04568, TABLET LOT# 84485