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

Model Number ZCT600

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

Patient Problems Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown/asked but unavailable.Best estimate is between (b)(6) 2019 - (b)(6) 2020.(b)(4).The device was manufactured at the (b)(4) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was explanted from the patient's left eye due to the patient having a history of keratoconus, therefore, it is difficult to get accurate measurements.The lens was not the right fit for the patient after all.The patient had blurry vision and had a hard time reading.The incision was enlarged, unplanned sutures, and an anterior vitrectomy were required.The replacement lens was successfully implanted with a different model and lower diopter.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

Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 7/13/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, which is consistent with a lens that was handled during explant.The lens was also observed to be returned covered in fibers, which may have occurred during the handling of the lens after explant, and therefore cannot be confirmed to be related to manufacturing.Based on the return condition of the lens no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.As a result of the investigation, with limited information available, it could not be determined if there.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10253878
• MDR Text Key: 198526737
• Report Number: 2020664-2020-00038
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474604025
• UDI-Public: (01)05050474604025(17)220620
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• 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: 06/12/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 10/25/2020
• Supplement Dates FDA Received: 08/29/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention