MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON ENDOCOAT; OVDS

Model Number HEALON ENDOCOAT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.If explanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that toxic anterior segment syndrome (tass) case occurred in a patient.Healon pro, lot# uh31179 and healon endocoat, lot# 028612, were used.It was stated that this case was the last case of the day.The patient is doing well after being started on steroid treatments.Upon further follow-up, the contact person does not have the product used during this case to send back for evaluation.The patient was treated with lotemax (steroid) every 1 hour and besivance (antibiotic) every 2 hrs.At last appointment, vision is improving.It was learned that both the healon pro and the healon endocoat are kept in the refrigerator until the morning of the case.The temperature log that day of the case did not show any change in temperature that would be out of the normal range.No other information was provided.This mdr report pertains to the healon endocoat.A separate report will be submitted for the healon pro.

Manufacturer Narrative

Device evaluation: no product was returned hence reported complaint cannot be verified.However, stock assessment was reviewed.No growth complaint suggests possible infection due to product use.Process step result release, no growth.Lot meets sterility specification.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Event appears to be an isolated occurrence.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10767138
• MDR Text Key: 214114159
• Report Number: 3004750704-2020-00052
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)220331(10)028612
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: HEALON ENDOCOAT
• Device Catalogue Number: 51031000
• Device Lot Number: 028612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/31/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR