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

Date of event: unknown, information not provided.Catalog #: a complete catalog # is unknown as serial number was not provided.Expiration date: unknown, as the serial number was not provided.Serial number: unknown, information not provided.Udi number: unknown, as the serial number was not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Device manufacture date: unknown as serial number was not provided.(b)(4).Device evaluation: the complaint sample was not returned to the manufacturing site; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: manufacturing record review cannot be performed since the serial number is unknown.A search of complaints related to serial number cannot be performed since the serial number is unknown.Conclusion: no sample was returned and serial number is unknown an investigation could not be performed, and no malfunction is confirmed.No escalation is required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Article: clinical outcomes of tecnis toric intraocular lens implantation after cataract removal in patients with corneal astigmatism.Citation: kevin l.Waltz, kristen featherstone, linda tsai, debbie trentacost., clinical outcomes of tecnis toric intraocular lens implantation after cataract removal in patients with corneal astigmatism.Ophthalmology 2015;122:39-47 2015 by the american academy of ophthalmology.

Event Description

The following article was received based on a literature review: clinical outcomes of tecnis toric intraocular lens implantation after cataract removal in patients with corneal astigmatism.The publication reports 4 eyes required lens repositioning, and two eyes had retinal repair procedures.Reportedly it is not indicated what the repair was for.5 models of lens were reported, however it is unknown which model was associated with lens repositioning and retinal repair procedure.Five toric lenses had an axis shift of 10 degree or more between 1 day and 6 month.This report will capture 1 model, 4 more reports are being submitted for other models.

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: 9477428
• MDR Text Key: 174854336
• Report Number: 9614546-2019-01108
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/04/2020

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: ZCT150
• Device Catalogue Number: ZCT150
• 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: 11/18/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention