MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. OXYSEPT; ACCESSORIES

Model Number OXYTC

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided date of event: unknown, information not provided.Lot number is unknown, not provided.Udi number is unknown as the lot number was not provided.Expiration date is unknown as the lot number was not provided.Manufacturing date is unknown as the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a consumer bought a new package of oxysept for the new lens case and noticed mold after using it for a while.She was unable to provide the date of event.It was noted the directions for use were followed, however, it unknown when the product was first opened for use.No further information was provided.

Manufacturer Narrative

Corrected data: in review of follow-up #1 it was observed there is a typo in the comment regarding review of the previous 12 months complaints for the product family.The statement: a total of seven complaints were found, however, the product deficiency was determined, is incorrect.The correct statement should read as: a total of seven complaints were found, however, a product deficiency was not determined.Also, section h3 device evaluated by manufacturer should have been checked yes, as an evaluation by the manufacturing site was conducted, although the device was not returned and the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: lot number was unknown.So, manufacturing record review was not available.A search of complaints revealed for the product family was conducted based on the previous 12 months.A total of seven complaints were found, however, the product deficiency was determined.Conclusion: based on the results of the investigation there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: OXYSEPT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10834555
• MDR Text Key: 216687906
• Report Number: 3004178847-2020-00031
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OXYTC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYSEPT SOLUTION AND TABLETS LOT# UNKNOWN