HEALON HEALON 5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for HEALON HEALON 5 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[183072233] Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Lot number : unknown/not provided unique identifier (udi#) : unknown as lot number was not provided. Expiration date : unknown as lot number was not provided. If implanted; if explanted; give date: n/a (not applicable). The viscoelastic is not an implantable device. (b)(6). Device manufacture date : unknown as lot number was not provided. Device evaluation: since no sample was returned and no lot number is provided an investigation could not be performed. Therefore a product deficiency is not confirmed. Manufacturing records review: manufacturing record review could not be performed since no lot number provided. Since no sample was returned and no lot number is provided an investigation could not be performed. Therefore a product deficiency is not confirmed. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[183072234] It was reported the chamber was narrow of hyperop patient (+6d), acd (anterior chamber depth) 2. 25. Chamber was filled with healon v and surgeon began sculpting. Immediately it looked dusty, smoky at the tip. Stopped and checked to make sure everything was ok. Continued to sculpt but it became smoky, milky, dusty again at the tip and phaco seemed highly ineffective. Stopped again and noted phaco burn (corneal incision contracture-cic) at the main section. Removed the phaco handle from the eye and checked to make sure everything was ok. The device did not signal anything, flushed out. Healon v was replaced with regular healon. Continued with the same handle, went well, phaco behaved as usual. Lens was removed and intraocular lens implanted. Surgeon had great trouble finishing the cut which had to be sutured with a lot of effort to get it tight. Patient risked getting pronounced postoperative astigmatism. The patient will be followed. Surgeon believes it may be related to viscoelastic, model healon v. Through follow-up additional information was provided. There were three sutures required, the expected outcome of the patient is severe postoperative astigmatism, and no further treatment is currently planned. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004750704-2020-00018
• MDR Report Key: 9821844
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-11
• Date of Report: 2020-03-11
• Date of Event: 2020-01-31
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-12
• Date Added to Maude: 2020-03-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: RAPSGATAN
• Manufacturer City: UPPSALA 751 82
• Manufacturer Country: SE
• Manufacturer Postal Code: 751 82
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: HEALON
• Generic Name: OVDS
• Product Code: LZP
• Date Received: 2020-03-11
• Model Number: HEALON 5
• Catalog Number: HEALON 5
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-11
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-11