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

Model Number	ZLB00
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol), there were some difficulties injecting the lens (into the eye) and the lens was scratched.No patient injury reported.Additional information was received and it was learned that the lens was cut and removed (from the eye) and a new lens was implanted.No vitrectomy was performed and no sutures were required.No further information was provided.
Additional Manufacturer Narrative
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 remove and replacement possible.Considering the condition of the lens additional analysis was not possible.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The complaint related test is the cosmetic inspection performed at final inspection.Only units that meet cosmetic inspection criteria are then subject to optical inspection.The in-line optical inspection data shows the lens is within power specification; hence the lens meets the specified cosmetic requirements.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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5931316
• Report Number: 9614546-2016-00438
• Device Sequence Number: 773786
• Product Code: MFK
• UDI-Device Identifier: 05050474560666
• UDI-Public: (01)05050474560666(17)190415
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 10/26/2016

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: Physician
• Device Expiration Date: 04/15/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR