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

Model Number ZCT

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of birth : only year provided (b)(6).Date of event: exact date unknown/ not provided, best estimate is between (b)(6) 2020 (b)(6) 2020 (date of lens repositioning procedure).Serial#: unknown/not provided.Model# and catalog#: only partially known expiration date: unknown as product serial number was not provided.Udi# is unknown as product serial number was not provided.If explanted; give date: not applicable, lens remains implanted.Phone: (b)(6).Device manufacture date: unknown as product serial number was not provided.(b)(4).Device evaluation: the product testing could not be performed as the device remains implanted.The complaint cannot be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the serial number is unknown.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 and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a toric model intraocular lens rotated counterclockwise in the right eye of the patient post implantation, and there was a need to reposition the lens.Additional information was provided, the patient had high astigmatism, and the lens rotation was from 115 to 135 degrees.Repositioning of the lens was performed in a secondary surgical procedure.Visual acuity post-op (b)(6).No patient injury was reported, and 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 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: 10422205
• MDR Text Key: 203465688
• Report Number: 9614546-2020-00319
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)(10)UNKNOWN
• 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 Model Number: ZCT
• Device Catalogue Number: ZCT
• 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: 07/22/2020
• Initial Date FDA Received: 08/18/2020
• 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