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

Model Number	ZCT150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during 2020.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(4).The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaint folder has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, to date, no response has been received.Note: the device was manufactured at the (b)(4) which has been closed.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that 1-month post op the zct lens has weird defect in the posterior lens itself.Hence the surgeon was planning to exchange the lens.Additional information indicates the lens was explanted in secondary surgical procedure.No further information provided.
Additional Manufacturer Narrative
Corrected data: upon review of this file it was found that section f13 in follow-up #1 was inadvertently not completed causing the date populated in g4 not to be communicated/received by fda.Therefore this supplemental report is being submitted.Date populated in follow-up #1 section g4 is (b)(6)/2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes; returned to manufacturer on: (b)(6)2020 section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received submerged in an unknown solution inside a specimen cup.A shipping label and a completed johnson & johnson shipping guide were received as well.Visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.The lens was cleaned.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.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: 10246784
• Report Number: 2020664-2020-00037
• Device Sequence Number: 572778
• Product Code: HQL
• UDI-Device Identifier: 05050474552203
• UDI-Public: (01)05050474552203(17)210705
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020; 09/23/2020; 10/25/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/10/2020; 09/24/2020; 10/29/2020
• 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