MAUDE Adverse Event Report: JOHNSON AND 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 Codes	Headache (1880); No Code Available (3191)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a multifocal intraocular lens (model zlb00 +26.0 diopter) was implanted in the left eye of a female patient on (b)(6) 2017.The lens was later explanted on (b)(6) 2018 because the patient was not satisfied with the vision.Reportedly, the patient complained of headaches.A monofocal lens (model zcb00 + 26.0 diopter) was implanted as a replacement.The incision was not enlarged to remove the multifocal lens and a vitrectomy was not performed.The patient was reported being better with the zcb00 lens.No further information was provided.
Additional Manufacturer Narrative
The intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.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 and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7404229
• Report Number: 9614546-2018-00327
• Device Sequence Number: 679478
• Product Code: MFK
• UDI-Device Identifier: 05050474560796
• UDI-Public: (01)05050474560796(17)200302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018

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: 03/02/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 07/04/2018
• 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: 67 YR