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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: although an exact date was not provided, the initial report stated the rotation was noted one week post implant, thus (b)(6) 2018 is provided as a best estimate.If explanted; give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as to date it remains implanted.A product quality deficiency could not be confirmed.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no similar complaints were received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.Conclusion: as a result, of the investigation there is no indication of a product malfunction or 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 that the zct450 14.5 diopter intraocular lens (iol) was implanted in the patient¿s right eye (od) on (b)(6) 2018.One week post-op it was reported the lens rotated 10 degrees counter-clockwise and visual acuity was 20/70.Through follow up, customer confirmed that the patient did not have any health related issue and/or medications that could have contributed to the zct450 rotation.Although there was minimal rotation counter clockwise again, the patient has elected to wear prescription glasses because it corrects to 20/20 od with refraction of -1.00 +1.25 x 045.No additional information was provided to johnson & johnson surgical vision.
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; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8158340
• Report Number: 9614546-2018-01164
• Device Sequence Number: 252457
• Product Code: HQL
• UDI-Device Identifier: 05050474602878
• UDI-Public: (01)05050474602878(17)230605
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U145
• 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: 11/13/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 11/05/2020
• 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: Other
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005