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

Model Number ZCT600

Device Problem Unintended Movement (3026)

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

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: product testing could not be performed because the product remains implanted.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from 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 a zct600 intraocular lens (iol) was implanted in the patient¿s right eye.After a few months, it was stated that the iol rotated.Initial orientation was 87 degrees, observed orientation was 70 degrees.Day of procedure (b)(6) 2019 iol was rotated 17 degrees clockwise /rotation.It was noted that visual issues were glare and fuzzy vision which affected the patient¿s daily activities.Repositioning was done after a week.The iol remains implanted.No patient post-op injuries, excellent patient outcome.No other 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.

• 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: 9528278
• MDR Text Key: 182702712
• Report Number: 9614546-2019-01132
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474604148
• UDI-Public: (01)05050474604148(17)200610
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 06/10/2020
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U190
• 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: 12/02/2019
• Initial Date FDA Received: 12/28/2019
• 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
• Patient Age: 64 YR