MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS

Model Number ZCU300

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted, give date: not applicable, as the lens remains implanted.Initial reporter address: unknown/ not provided.Initial reporter phone number: unknown/ not provided.The device is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

In a clinical research study, during a monitoring visit, the site noted an intraocular lens (iol) rotation of 19 degrees in the patient¿s right eye (od) on (b)(6) 2020.Iol axis placement: 95 pre-operation best corrected visual acuity (bcva): 20/25 od; 20/100 os.1-week visit on (b)(6) 2020: uncorrected distance visual acuity (ucdva): od: 20/15 -1, iol axis placement: 76.It was indicated that there no plans for intervention at this time.The subject was scheduled to come in for the 3-month visit on (b)(6) 2020.The subject had the 3-month post-operational vision on the right eye (od) on (b)(6) 2020.The axis placement was reported at 79 degrees.There was no product complaint reported.The patient denied any visual complaints or symptoms.No planned intervention was reported.The doctor determined that the change in axis was probably due to head tilt day of surgery given good outcome of visual acuity.Uncorrected distance visual acuity (ucdva): od- 20/25-2, bcdva- 20/20+1.No additional information was reported.

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 TORIC II 1-PIECE ACRYLIC
• 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: 10445855
• MDR Text Key: 205713258
• Report Number: 9614546-2020-00330
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474660038
• UDI-Public: (01)05050474660038(17)241003
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U140
• 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: 07/30/2020
• Initial Date FDA Received: 08/24/2020
• 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