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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate (b)(6) 2019 to (b)(6) 2019.If explanted; give date: not applicable, lens remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the doctor to his johnson & johnson sales representative during a conversation, that he had patients who's intraocular lenses (iol) had rotated post op.The lenses were all model zct lenses.The doctor stated that the rotation was about 10-15 degrees and this happened over the course of the last few months.The following information was provided for patient number 1.The intraocular lens rotated counter clockwise, the degree of rotation unknown, in the patient's left eye.The patient was taken back to surgery, (b)(6) 2019, for a repositioning.The patient did well post op.Patient's visual acuity post op implant and before repositioning was 20/50 and 20/25 post repositioning.No further information was provided.
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
• 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: 9141702
• Report Number: 9614546-2019-00932
• Device Sequence Number: 13909581
• Product Code: HQL
• UDI-Device Identifier: 05050474553934
• UDI-Public: (01)05050474553934(17)230103
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2023
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U210
• 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: 09/09/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005