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

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Sex/gender: unknown/ not provided.The healon pro is not an implantable device; therefore, not explanted.(b)(6): the healon pro ophthalmic viscosurgical device (ovd) is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the follow-up visit of a patient implanted with a aab00 intraocular lens (iol), a gray-silver mist or film was detected in the eye.In a second surgery this was aspirated.The aab00 was clear.Our customer suspects that this was caused by remnants of healon pro and iris pigments.Through follow-up, we learned that the patient complained about blurry vision which has improved since the second surgery, everything is fine, lens is clear, and the patient looks good.No additional information was provided.This report captures the event for the healon pro viscosurgical device.A separate report is being submitted for the aab00 intraocular lens.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and (b)(4).

• Brand Name: HEALON PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8589685
• MDR Text Key: 144396104
• Report Number: 3004750704-2019-00014
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609631
• UDI-Public: (01)05050474609631(17)211231(10)UE30969
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: TH85ML
• Device Catalogue Number: 10270012
• Device Lot Number: UE30969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AAB00 INTRAOCULAR LENS SN: (B)(4); AAB00 INTRAOCULAR LENS SN: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR