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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not applicable, as lens was removed/replaced in the initial surgery.Not applicable, as lens was removed/replaced in the initial surgery.Attempts were made to obtain missing information; however, to date a response has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted, the doctor noticed a broken haptic probably due to a loading issue.The lens was removed and replaced and there were no patient problems.A folding problem was also reported.No additional information was provided.
Additional Manufacturer Narrative
Additional and corrected information was received with the following information: patient gender and date of birth.The physician's name and address.The replacement lens.No incision enlargement was performed.No further information was provided.The following sections have been updated accordingly: patient age/date of birth: (b)(6) 1948, patient gender/sex: female.Initial reporter: (b)(6), initial reporter health professional: yes, initial reporter occupation: physician.Device evaluation: the sample was received on 07/01/19.The sample was evaluated and viscoelastic residue along with cut lens was observed.The lens was cut where the loop is attached.The condition observed is consistent with a lens that has been explanted.The reported issues were not verified.The haptic detached and lens cut was confirmed but it could not be determined if the condition observed is related to manufacturing process.The reported lens was used and cut in a surgical procedure.Based on the product return evaluation, a product quality deficiency or product malfunction could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that 1 other complaint has been received for this production order number.Investigation request completed and product met manufacturing release criteria.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 (b)(4) and capa-010215.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8760975
• Report Number: 2648035-2019-00686
• Device Sequence Number: 1342237
• Product Code: HQL
• UDI-Device Identifier: 05050474530782
• UDI-Public: (01)05050474530782(17)231025
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2023
• Device Model Number: Z9002
• Device Catalogue Number: Z900200245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 10/25/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/12/2019; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005