MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the implantation of lens model, zcb00 monofocal iol (intraocular lens) there was a mechanical complications.The lens was explanted and replaced with +23.5 diopter zcb00 lens.No complications were reported after replacement.No additional information provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient's date of birth is (b)(6) and the affected eye is the patient's left (os) eye.No further explanation regarding the event was provided.Based on the new information received for the patient as well as the doctor, the following fields were updated accordingly: (b)(6).Initial reporter name: dr.(b)(6), health professional; occupation: physician.Device available for evaluation; returned to manufacturer on: 3/21/2019.Device evaluation: the lens was received at the manufacturing site for evaluation.The reported lens returned cut in two pieces.The cut could be related to the explant process.Both haptics were observed in good form.A product quality deficiency could not be determined.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search in complaints history revealed that no additional investigation request has been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 1-PIECE
• 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: 8446510
• Report Number: 2648035-2019-00376
• Device Sequence Number: 13522437
• Product Code: HQL
• UDI-Device Identifier: 05050474531505
• UDI-Public: (01)05050474531505(17)210418
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: health professional,user faci
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 10/25/2020
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/06/2019; 11/11/2020
• 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: 83 YR
• Date Report Sent to FDA: 01/01/2005