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

Date of event: unknown, information not provided.Timeframe of usage was reported as end of september, early (b)(6) 2020.Unique identifier: udi# is unknown as lot# was not provided.Expiration date: unknown, as lot number was not provided phone: (b)(4).Device manufactured date: unknown, as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the consumer's concept 1-step lens case had gotten moldy on the white filter (gortex) attached to the back of the lid of her case when one-half to two-thirds of the disinfectant solution had been used.The product was used at the end of september, early (b)(6) 2020.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

Additional information kit lot number provided, therefore the following fields have been populated.Section d4: lot# - kit lot number provided as zh05136.Section d4: expiration date: 12/31/2021.Section h4: device manufacture date: 4/18/2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 11/10/2020 section h3: device returned to manufacturer ¿ yes.Device evaluation: by checking the returned oxycup, black substance was observed on the cap.According to the initial report, the contamination was found during product use, and it could not be confirmed whether dfu was followed, thus, no product deficiency was confirmed.Manufacturing record review: reported lot number zh05136 was a kit lot.Its filling lot zh05134 and compounding lot zh05133 were manufactured in apr 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 complaint data was for the previous 12 months was conducted by the reported lot number: zh05136; search result: total 2 complaints were reported in previous 12 months.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: 10833581
• MDR Text Key: 216179737
• Report Number: 3004178847-2020-00030
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: ZH05136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT ZH05135, TABLETS LOT 84898