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

Model Number ZCT800

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Sex/gender: unknown/ not provided.If implanted; give date: unknown/not provided.If explanted; give date: not applicable as lens remains implanted.(b)(6).(b)(4).Device evaluation: the product testing could not be performed as the product remains implanted.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no additional complaint folder 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that surgeon observed the day after a toric model intraocular lens was implanted, that the lens rotated 17 degrees.The doctor had to perform a second surgery (lens repositioning) to place the iol again in the right position.After the second intervention the patient's outcome was ok.No additional information 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 (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: 10323921
• MDR Text Key: 200386955
• Report Number: 9614546-2020-00274
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474591103
• UDI-Public: (01)05050474591103(17)231018
• 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: 01/01/2005,10/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: ZCT800
• Device Catalogue Number: ZCT8000130
• 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: 06/29/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR