MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS CL; MONOFOCAL IOLS

Model Number Z9002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Additional information: if implanted; if explanted; give date: not applicable as the iol was not implanted.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that one (01) additional investigation request (ir) for this production order number has been received.The complaint issue is a low risk and no investigation was required, therefore this complaint issue was not confirmed.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was inserted and removed from patient¿s ocular sinister (left eye) due to capsular break.No lens was implanted in the patient¿s eye as the doctor is waiting for the patient to heal and will implant an iol on a future date.The incision was enlarged, suture(s) were required, and vitrectomy was performed.No additional information was provided.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information 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 capa (b)(4).

Manufacturer Narrative

Additional information was received, and the following fields were updated accordingly: device available for evaluation: yes.Returned to manufacturer on: 07/29/2020.Device returned to manufacturer: yes.Device evaluation: the lens associated to the complaint was received in the original folding carton and lens case.The lens has what appears to be viscoelastics and/or other surgery related substance.The lens edges are smooth including the haptics tips that are polished/rounded.There are marks (cosmetic damages) on the iol that could be related to the reported lens removal and are not reported as part of the customer complaint.The reported issue cannot be verified.Based on the visual evaluation there is no indication that the reported broken capsule is related to the lens quality.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10317997
• MDR Text Key: 200285492
• Report Number: 2648035-2020-00547
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530737
• UDI-Public: (01)05050474530737(17)250212
• Combination Product (y/n): Y
• PMA/PMN Number: P880081
• 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: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Z9002
• Device Catalogue Number: Z900200220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• 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: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR