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

Model Number	ZA9003
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.Gender/sex: unknown/not provided.If implanted, give date: not applicable, as the lens was not fully implanted, but inserted and removed during the same procedure.If explanted, give date: not applicable, as the lens was inserted and removed during the procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation of a za9003 intraocular lens (iol), the trailing haptic was observed to be bent as the lens was being inserted.The lens was cut in half and removed.The physician noted that the capsule bag broke and a non-amo device was used as a lens replacement.Through follow up the customer indicated that there was no record of incision enlargement for this event.The procedure was completed with no further issues reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 1/31/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Device inspection was performed and the lens was cut into two pieces.Visual inspection at 10x microscope magnification was performed and both haptics are distorted / bent.The reported haptic damaged was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6260861
• Report Number: 2648035-2017-00122
• Device Sequence Number: 16311963
• Product Code: HQL
• UDI-Device Identifier: 05050474529120
• UDI-Public: (01)05050474529120(17)190513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 03/08/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/13/2019
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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