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

Model Number	ZMA00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event was not provided.It is noted that the lens decentered the week of (b)(6) 2016.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the zma00 intraocular lens (iol) was removed/explanted from a male patient's left (os) eye as it was decentered.It was noted that the lens was decentered the week of (b)(6) 2016, and the doctor centered the iol.The iol became decentered again the following week and the patient got double vision.The patient was scheduled for surgery on (b)(6) 2016, the iol was removed and another manufacturer's lens was implanted as a replacement.It was noted that the reason for the iol decentration was unknown.There were no incision enlargement, vitrectomy and/or sutures required.There was no patient injury post-op reported.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in half, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not 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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6059395
• Report Number: 9614546-2016-00546
• Device Sequence Number: 2102154
• Product Code: MFK
• UDI-Device Identifier: 05050474536715
• UDI-Public: (01)05050474536715(17)190624
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/24/2019
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 12/16/2016
• 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