MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 5 PRO; OVDS

Model Number TV60ML

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

Patient age/ date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.If implanted, give date: not applicable, as the healon 5 pro is not an implantable device.If explanted, give date: not applicable, as the healon 5 pro is not an implantable device.The intraocular lens (iol) is not returning for evaluation as it was discarded by customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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 & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported a patient experienced capsular entrapment syndrome, experiencing some level of 2-3 diopter shifts following cataract surgery, requiring an immediate post-operative yttrium-aluminum-garnet (yag) laser procedure for correction.Issue was a result of residual healon 5 pro ophthalmic viscosurgical device (ovd) remaining in the eye, potentially posterior to the intraocular lens (iol), following surgery, even after what the surgeon describes as meticulous irrigation aspiration (ia) removal.The patient is doing fine, and progressing nicely according to the surgeon, and he has made the clinical decision to return to usage of the healon duet pro ovd product as a solution.Product was discarded and is not being returned.No additional information was provided.

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 nr-0148919 and capa-010215.

Manufacturer Narrative

Corrected data: in review, it was noted that sections d1 & d4 of the initial mdr report were populated incorrectly.Therefore, the information has been corrected in this supplemental report.The following fields were updated accordingly: section d1: brand name: healon 5 pro.Section d4: model #: tv60ml.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON 5 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: 10365671
• MDR Text Key: 201878052
• Report Number: 3004750704-2020-00042
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474636996
• UDI-Public: (01)05050474636996(17)230131(10)UH31112
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TV60ML
• Device Catalogue Number: 10240015
• Device Lot Number: UH31112
• 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
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention