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 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Sex/gender: unknown/ not provided.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.Concomitant medical products: intraocular lens, model zcb00, balanced salt solution (bss) irrigation solution, prol ystica, quick rinse.Phone number: unknown/ not provided.Other: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that toxic anterior segment syndrome (tass) occurred in the left eye of a patient.Besivance ophthalmic eye drops 3x daily for 1 week (normal post cataract order) was prescribed to the patient.It was indicated that the was a severe inflammation; however, the patient has recovered.The lens remains in the patient's eye.No further information was provided.This emdr report is for the healon endocoat device.A separate emdr is being submitted for the intraocular lens, model zcb00.

Manufacturer Narrative

Additional information received from customer, indicated the patient was a female and that the post-op drops given to the patient were ofloxacin, lotemax and prolenza.The following fields were updated accordingly: section a3: sex/gender: female; section b2: outcomes attributed to adverse event: required intervention; section d11: concomitant medical products: phaco machine, sn unknown, phaco disposable tubing, lot unknown.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: 11042220
• MDR Text Key: 222620964
• Report Number: 3004750704-2020-00074
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)220131(10)028551
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: HEALON ENDOCOAT
• Device Catalogue Number: 57502000
• Device Lot Number: 028551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR