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	Vertigo (2134); Blurred Vision (2137); No Code Available (3191)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an explant of an intraocular lens, model zlb00, was performed on the right eye (od) of a female patient due to the patient complaint of vertigo and blurry vision.The lens was replaced with a model zcb00 lens, 20.0 diopter.There was no incision enlargement, vitrectomy or sutures required and there was no post-op injury reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 4/21/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection with the unaided eye shows the product is damaged, most probably to make explant possible.Considering the condition of the lens the damage was not introduced during design or manufacturing.The complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this product order number to date.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: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6474730
• Report Number: 9614546-2017-00285
• Device Sequence Number: 608388
• Product Code: MFK
• UDI-Device Identifier: 05050474560673
• UDI-Public: (01)05050474560673(17)190410
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 04/10/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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: 75 YR