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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/ date of birth: unknown/ not provided.Sex/ gender: unknown/ not provided.Date of event: rotation occurred between the (b)(6) (implantation) and the (b)(6) (check-up visit and rotation).If explanted; give date: not applicable as the lens remains implanted.(b)(6).(b)(4).Product evaluation: the intraocular lens (iol) is not returning for evaluation as it remains implanted following lens rotation; therefore, a failure analysis of the complaint device cannot be completed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a toric lens had to be rotated.Through follow-up we learned that the lens was implanted on the (b)(6) 2020, and was rotated in a secondary procedure 30 degrees counter clockwise at the check-up 7 days later on the (b)(6) 2020.The exact incident date is unknown and no further interventions or patient injuries have been reported.The case was noted as standard, axial length (al) 24.50mm.On the (b)(6) the post-rotation check up results were noted as ucva (uncorrected visual acuity) 20/15.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 (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: 10110034
• MDR Text Key: 193362061
• Report Number: 2648035-2020-00431
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474538177
• UDI-Public: (01)05050474538177(17)240113
• 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: 01/01/2005,10/30/2020

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: 01/13/2024
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT1500205
• 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: 05/06/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention