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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: not applicable, as the lens was inserted and removed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor was trying out a smaller blade to make incision enlargements before cataract implantation.The doctor inserted the insertion system, encompassing a zcb00 28.0 diopter lens, into the ''smaller'' incision site and as the lens advanced into the patient's right eye (od), the leading haptic caught on the incision site.Therefore, the insertion system/lens was removed, the incision site was enlarged, and then replaced with a back up lens of the same model and diopter.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
In review, the initial emdr was reported as reportable incorrectly.The event occurred due to a handling problem where the physician used a smaller blade to purposely make the incision size smaller, which is not reportable.Therefore, no more reporting will be filed under mdr report number 2648035-2018-01111.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-(b)(4) and capa-(b)(4).

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7793043
• Report Number: 2648035-2018-01111
• Device Sequence Number: 1249344
• Product Code: HQL
• UDI-Device Identifier: 05050474531871
• UDI-Public: (01)05050474531871(17)211010
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 11/02/2020
• 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: 10/10/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/22/2018; 10/25/2020
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/04/2018; 11/02/2020
• 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: 70 YR
• Date Report Sent to FDA: 01/01/2005