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

Model Number	ZCU300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10445855
• Report Number: 9614546-2020-00330
• Device Sequence Number: 2676405
• Product Code: HQL
• UDI-Device Identifier: 05050474660038
• UDI-Public: (01)05050474660038(17)241003
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005