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 09/26/2020

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.(b)(4).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 which was implanted with an intraocular lens.Moxifloxacin ophthalmic eye drops were given as a normal pre and post regimen.The patient was also taking durezol eye drops every 1-2 hours.In addition, the patient was given a medrol dose pak 4mg tablets po (use as directed) on (b)(6) 2020 post surgery.It was noted that the patient has recovered.The lens remains in the patient's eye.The account indicated that they have been doing an investigation and at this point they do not know where the tass is coming from.No further information was provided.This emdr report is for the healon endocoat device.A separate emdr will be submitted for the intraocular lens, model zcu450.

Manufacturer Narrative

Additional information/corrected data: additional information received indicated that the post-op drops given to the patient were moxifloxacin, ketorolac, prednisolone.Also, initially the account reported ''(b)(6) 1950'' to be the date of birth for the patient which was entered in the initial emdr report.However, additional information received from the account clarified that the correct date of birth for the patient is ''(b)(6) 1950''.Therefore the following field was updated accordingly: section a2: age/date of birth: (b)(6) 1950.Upon further review of the complaint file, it was noted that the event reported for the healon endocoat product, lot 028612 under the manufacturer #3004750704-2020-00075 was a duplicate of an earlier event which had already been reported under the manufacturer report #3004750704-2020-00054.Therefore, no further information will be provided under this medwatch #3004750704-2020-00075 as it has now been determined to be a duplicate report.All pertinent information available to johnson and 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: 11062302
• MDR Text Key: 223372800
• Report Number: 3004750704-2020-00075
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS MODEL ZCU450, SN (B)(6); LENS MODEL ZCU450, SN (B)(4)
• Patient Outcome(s): Other
• Patient Age: 69 YR