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 Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Gender/sex: unknown, information not provided.Age/date of birth: unknown, information not provided.Date of event: exact date unknown, information not provided.Best estimate is (b)(6) 2020.About a week before the consumer called on (b)(6) 2020.Lot number: unknown, not provided.Udi number: unknown, as the lot number was not provided.Expiration date: unknown, as the lot number was not provided.Device manufacturing date: unknown, as the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Received report from a consumer stating that a mold-like substance was observed on the filter behind the lid of the contact lens case/cup of consept 1-step product.Consumer rinses the case in water and lets it dry naturally.The product was opened in (b)(6) 2020 and the occurrence was about a week before the report was received, best estimate is (b)(6) 2020.No further information was provided.

Manufacturer Narrative

Additional information: section d4: kit number was provided ze07500.Section d4: expiration date 07/31/2021.Section h4: device manufacture date 07/11/2019.Device evaluation: by checking of the returned samples, no lens cup was returned, so, the reported issue can not be confirmed.Microbiological testing was not required since no contamination of solution or infection to the customer was reported.Manufacturing record review: reported solution lot number ze07383 was a labelling lot.Its filling lot ze07382 and compounding lot ze07381 were manufactured in nov 2019.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: ze07383; search result: total four 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.

Manufacturer Narrative

Device evaluation: manufacturing record review: the reported lot number ze07500 was a kit lot and it was packaged in nov 2019.All the records for production process were found to be acceptable, all testing items were completed and met specifications, including incoming primary materials inspection and product physical appearance inspection.There was no non-conformance related to this complaint.Complaint data was trended in previous 12 months by the reported lot number: ze07500; search result: total five 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: 10571657
• MDR Text Key: 208147644
• Report Number: 3004178847-2020-00020
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2020

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: 07/31/2020
• Device Model Number: AGNCG
• Device Catalogue Number: AGNCG
• Device Lot Number: ZE07500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 12/06/2020
• Supplement Dates FDA Received: 11/26/2020; 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT# ZE07383, TABLETS LOT# 83036; SOLUTION LOT# ZE07383, TABLETS LOT# 83036