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

Model Number ZCT225

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown / not provided.If implanted; give date: unknown / not provided, if explanted; give date: not applicable as the lens remains implanted.(b)(6).(b)(4).Device evaluation: the product testing could not be performed as the lens remains implanted.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed that no similar complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that model zct intraocular lenses (iols) were implanted in a male patient's both (ou) eyes.During post-operative examination, both lenses were found to have rotated 20-30 degrees clockwise away from the original axis and the visual (va) dropped.The lenses were repositioned in a secondary procedure on (b)(6) 2019.It was noted that sutures were required and no other surgical interventions such as vitrectomy or incision enlargement were needed.This report pertains to the lens in the patient's right eye (od).A separate report will be 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-(b)(4) 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: 9336573
• MDR Text Key: 166826983
• Report Number: 9614546-2019-01044
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474538528
• UDI-Public: (01)05050474538528(17)220925
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/05/2020

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: 09/25/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT2250085
• 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: 10/24/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention