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

Model Number ZCT450

Device Problem Unintended Movement (3026)

Patient Problems Retinal Detachment (2047); Blurred Vision (2137); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is from (b)(6) 2019 to present.If explanted; give date: not applicable; lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed and no deviation was found during processes related to the complaint issue reported.The product was manufactured and released according to specification.A search in the complaint system revealed that no other complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

A male patient reported that he was implanted with an intraocular lens (iol), model zct450 10.0 diopter in the right eye (od).One-day post-op, (b)(6) 2019, the lens had to be repositioned due to a 108-degree rotation.No other surgical interventions and no patient injury were reported when the lens was repositioned.The patient reports blurry vision sometimes with signs and television, and he has glare issue at night time when driving.It was noted that the symptoms are not debilitating, and he is able to perform his daily tasks/activities.The patient also reported that he had detached retina after the lens was repositioned.His doctor told him that it was due to patient¿s stretched/very tight retina.The patient was referred to a retina specialist who stitched his retina and gave him gas treatment to resolve the issue.The patient also reports bad astigmatism in both eyes (od: 4.25 and os: 3.0).The patient was given progressive readers to use for close range and when he is on computer.Prescription for od: sphere: +0.5, cylinder: -1.0, axis: 163 and magnification: 2.5.No additional information was provided.This report pertains to the patient's right eye (od).A separate report is being submitted for the patient's left eye (os).

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.

• 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: 9684116
• MDR Text Key: 178545261
• Report Number: 2020664-2020-00010
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474602786
• UDI-Public: (01)05050474602786(17)230530
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/03/2020

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: 05/30/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U100
• 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: 01/13/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention