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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.Email address: unknown, information not provided.The intraocular lens (iol) is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(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 from the patient due to the patient being dissatisfied.The explanted lens was discarded.There was no patient injury reported.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Through follow-up the customer provided the patient's date of birth, stated the replacement lens zcb00 21.5d, and reported the patient was complaining about having issues with glare.There was no vitrectomy, capsule tear, incision enlargement or no other patient injury.The patient is doing good post operatively.No additional information was provided.The following section has been updated accordingly: age/date of birth: (b)(6).(b)(4).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-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: 8778862
• Report Number: 2648035-2019-00717
• Device Sequence Number: 1822740
• Product Code: MFK
• UDI-Device Identifier: 05050474535671
• UDI-Public: (01)05050474535671(17)220917
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 11/12/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0225
• 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: 06/12/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 10/25/2020
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/07/2019; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005