MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); Vitrectomy (2643); No Code Available (3191)
Date of Event	04/05/2017
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 initially reported that an explant of a model zmb00 (13.5 diopter) intraocular lens (iol) was performed on the right eye (od) of a female patient because of mechanical failure.A vitrectomy and new incision were required.The leading haptic was amputated and the optic was bisected.The lens was removed in two pieces.There was no suture required and no patient injury reported.Through follow up it was clarified that the reported mechanical failure was that the patient experienced bad halos and glare with the lens.The new incision was done due to the lens being implanted in the patient's eye for three (3) years so new incision was made to get the lens out.The vitrectomy was because of removing the lens and the patient had previously had a yag capsulotomy.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 05/11/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not be verified.Manufacturing records review: 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.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 abbott medical optics 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: 6549543
• Report Number: 9614546-2017-00371
• Device Sequence Number: 11035085
• Product Code: MFK
• UDI-Device Identifier: 05050474535497
• UDI-Public: (01)05050474535497(17)180106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: 01/06/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/11/2017
• 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: 68 YR