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

Model Number	ZCT150
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.Date of event: unknown.Best estimate is between (b)(6) 2019 to (b)(6) 2019.(b)(4), attempts were made to obtain missing information; however, to date, no response has been received.
Event or Problem Description
It was reported that a zct150 lens 26.5 diopter lens was explanted from the patient's right eye as the patient requested to see farther away.No more information was provided.
Additional Manufacturer Narrative
Device available for evaluation, yes.Returned to manufacturer on, 09/09/2019.Device returned to manufacturer: yes.Device evaluation: the product was received within a plastic resealable biohazard specimen bag and wrapped in medical dressing.A visual inspection of the lens showed traces of blood.The lens was received cut into multiple pieces, most probably to aid in explant, with the pieces stuck to the medical dressing.The condition of the return is consistent with a lens that was cut from the eye.Based on the condition of the return, further analysis is not possible.The complaint event could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: 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.
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: 8973452
• Report Number: 3011852734-2019-00177
• Device Sequence Number: 16863149
• Product Code: HQL
• UDI-Device Identifier: 05050474552272
• UDI-Public: (01)05050474552272(17)210803
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 08/03/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/13/2019; 10/25/2020
• Initial Report FDA Received Date: 09/08/2019
• Supplement Report FDA Received Date: 10/01/2019; 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
• Date Report Sent to FDA: 01/01/2005