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

Model Number	ZMA00
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: if implanted; give date: n/a.The lens was inserted into the eye, removed and replaced during the same procedure.Explant date: if explanted; give date: n/a.The lens was not explanted during a secondary procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that there was a folding issue with the intraocular lens (iol).The lens was fully implanted; however, it had to be removed within same procedure and replaced with another lens of the same model.During follow up, it was reported that after the lens was inserted, it did not unfold properly.The lens was removed with no incision enlargement or patient injury.There were no complications with the replacement procedure.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection revealed that the lens was damaged.One of the haptics was kinked.The condition of the lens is consistent with a product that was removed (from the eye) and do not suggest that the damage was introduced during manufacturing.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 additional 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.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: 5978173
• Report Number: 9614546-2016-00474
• Device Sequence Number: 813595
• Product Code: MFK
• UDI-Device Identifier: 05050474536869
• UDI-Public: (01)05050474536869(17)200528
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNFOLDER CARTRIDGE EMERALDC30, LOT CB32476
• Patient Age: 61 YR