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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown.Gender/sex: unknown.If implanted; give date: not applicable; lens removed/replaced within the initial procedure.If explanted; give date: not applicable; lens removed/replaced within the initial procedure.(b)(4).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 the intraocular lens (iol) got stuck in the wound.An incision enlargement was required and a replacement lens was used.Further, it did not contribute to a patient injury.There was no patient harm.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 9/09/2019.Device returned to manufacturer: yes.Device evaluation: the original lens box and daisy wheel lens casing were returned; however, no lens could be found within the return.No product evaluation could be performed.The reported complaint could not be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8975764
• Report Number: 3011852734-2019-00178
• Device Sequence Number: 10819592
• Product Code: MFK
• UDI-Device Identifier: 05050474560642
• UDI-Public: (01)05050474560642(17)220303
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• 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): 11/10/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 10/25/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/12/2019; 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
• Date Report Sent to FDA: 01/01/2005