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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Date of event: unknown, not provided; best estimate is between (b)(6) 2018 and (b)(6) 2018.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported a zct225 27.0 diopter intraocular lens (iol) was implanted in the patient¿s left eye (os) on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to unexpected post-op refraction and replaced with a zct150 25.5 diopter iol.Reportedly, the patient has recovered from the surgery.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation: yes.Returned to manufacturer on: 4/29/2019.Device returned to manufacturer: yes.Device evaluation: the sample was received inside of a plastic vial inside a biohazard re-sealable bag.Visual inspection with an unaided eye revealed only half of the lens to be returned, possibly due to explant.Further investigation is not possible; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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: 8534284
• Report Number: 3011852734-2019-00093
• Device Sequence Number: 1839787
• Product Code: HQL
• UDI-Device Identifier: 05050474552876
• UDI-Public: (01)05050474552876(17)210613
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 06/13/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 10/25/2020
• Initial Report FDA Received Date: 04/20/2019
• Supplement Report FDA Received Date: 05/16/2019; 11/12/2020
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005