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	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.  lens repositioned.Dysphotopsia - negative.It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis multifocal intraocular lens (model zlb00, +25.5 diopter) was repositioned post operative because of patient experiencing negative dysphotopsia (temporal shadow) post op in the left eye (os) that would not subside.The doctor repositioned the lens with the haptics oriented horizontally to mitigate the effects of temporal shadowing.The lens was not explanted.No enlargement of the incision occurred.The repositioning was performed without incident.The patient was reported to have no complaints post repositioning.No further information provided.
Additional Manufacturer Narrative
Additional information was received.It was reported the patient was not happy with the lens from the start.The lens was repositioned on (b)(6) 2018 and the patient was still not happy.It was learned that the explant was completed on (b)(6) 2018.Reportedly lens from another manufacturer was used as replacement lens for the patient gender/sex: male.Age: 66.If explanted, give date: (b)(6) 2018.All pertinent information available johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 8/1/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The sample was inspected by a qualified final inspection operator using 12x magnification.There are no anomalies found.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were 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.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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7497396
• Report Number: 9614546-2018-00445
• Device Sequence Number: 13872503
• Product Code: MFK
• UDI-Device Identifier: 05050474560789
• UDI-Public: (01)05050474560789(17)191005
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2018
• 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: Physician
• Device Expiration Date: 10/05/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 09/13/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/12/2018; 09/21/2018
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005