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

Model Number	ZMA00
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
When inserting the intraocular lens (iol) into the eye, the customer account reported that the iol was stuck in the plunger/cartridge and there was patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: visual inspection with the unaided eye shows the product was damaged, most probably due to the fact that the lens was not properly placed in the lens case.The lens was inspected by a qualified inspector using 12x magnification.It could be seen that the lens was contaminated as dust particles were present.This is expected as the lens was transported from a controlled environment during manufacturing to a non-sterile, non-environmentally controlled area.No other anomalies were found.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: 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: 6819684
• Report Number: 9614546-2017-00801
• Device Sequence Number: 1420076
• Product Code: MFK
• UDI-Device Identifier: 05050474536906
• UDI-Public: (01)05050474536906(17)200825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2017

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: 08/25/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1