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	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of the onset of symptoms was not provided.Date received by manufacturer: the exact date is unknown; therefore, a best estimated date has been provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a multifocal intraocular lens (iol), model zmb00, was explanted in a secondary surgical procedure because the male patient had an intermediate drop in vision.Reportedly, the lens was replaced with a different multifocal lens, model zkb00, the diopter size was not provided.Additional information was received and it was learnt that there was no incision enlargement, no vitrectomy was performed and no patient post-op injury was reported.The lens was discarded by the customer.Reportedly, there was a plan to explant the lens in late 2016, because of the visual issue.However, the patient kept on pushing the date off until (b)(6) 2017, when the lens was explanted.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: 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.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.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: 6449969
• Report Number: 9614546-2017-00258
• Device Sequence Number: 1378346
• Product Code: MFK
• UDI-Device Identifier: 05050474535503
• UDI-Public: (01)05050474535503(17)171001
• 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: 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): 05/26/2017

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: 10/01/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/26/2017
• 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