MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS 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	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.(b)(4).Planned explant; scheduled for about one month after the lens exchange for the right eye that is scheduled on (b)(6) 2017.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 7.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.There is a planned explant to happen one month after the iol exchange scheduled for (b)(6) 2017, in the right eye, due to the patient seeing extreme halos when driving at night and during the day.Also, the patient cannot function with these side effects.The replacement lens will either be model ar40e or pcb00.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Historical data analysis: the search in complaint history revealed 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 for the proper use and handling of the product.Conclusion: 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
In the initial emdr, the implant date of (b)(6) 2017 in section was incorrectly reported.Through follow up with the surgery center it was learned that the actual implant date was (b)(6) 2016.This section has been updated and corrected.If implanted, give date: (b)(6) 2016.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): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7047505
• Report Number: 9614546-2017-01139
• Device Sequence Number: 16619753
• Product Code: MFK
• UDI-Device Identifier: 05050474560420
• UDI-Public: (01)05050474560420(17)200224
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018
• 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: 02/24/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 02/15/2018; 08/13/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 03/15/2018; 08/15/2018
• 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: Other
• Date Report Sent to FDA: 01/01/2005