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

Model Number	ZCT525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided, best estimate is between (b)(6) 2019 - (b)(6) 2019.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted as there was a wrong lens power.No additional information was provided.
Additional Manufacturer Narrative
Through follow-up the patient's gender was provided.Therefore, the patient's gender field has now been updated accordingly.The date of event was previously reported with the best estimate date.The date of event was provided through follow up and the field has been updated accordingly.It was also reported there was no incision enlargement required.The lens was replaced with another model.The patient is doing well and in good condition.No additional information was provided.Patient ex/gender: female.Date of event: (b)(6) 2019.Device available for evaluation? yes.Returned to manufacturer on: 10/23/19.Device returned to manufacturer: yes.Device evaluation: visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 (b)(4) 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: 9143935
• Report Number: 9614546-2019-00934
• Device Sequence Number: 2700055
• Product Code: HQL
• UDI-Device Identifier: 05050474603363
• UDI-Public: (01)05050474603363(17)210509
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 05/09/2021
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• 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: 10/04/2019; 10/25/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/30/2019; 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
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005