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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019.If explanted, give date: explant is scheduled for (b)(6) 2020, however not yet confirmed.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that during the cataract surgery, a toric intraocular lens was placed in patient¿s right eye at 45 degrees on (b)(6) 2019.The toric lens was later repositioned to 30 degrees on (b)(6) 2020 due to patient experiencing rotation.Reportedly the lens will be explanted from patient¿s right eye in a secondary surgical procedure on (b)(6) 2020 as surgeon reported that patient is experiencing residual monocular diplopia, poor uncorrected distance vision with monovision, and has a history of myopic lasik in 1999.The patient needs a higher toric correction.The explant is not confirmed.No further information provided.

Manufacturer Narrative

Additional information was received and it was confirmed that explant took place.The following fields have been updated accordingly: section d7: if explanted, give date:(b)(6) 2020.Section h6: patient code 3191 ¿ explant.Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaints have been received for this po.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 has been submitted.

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: 10146819
• MDR Text Key: 195122935
• Report Number: 9614546-2020-00222
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474552104
• UDI-Public: (01)05050474552104(17)230411
• 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,health
• Type of Report: Initial,Followup,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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U180
• 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: 05/19/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 10/25/2020
• Supplement Dates FDA Received: 07/13/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention