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

Model Number	ZCT225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct225 19.5 diopter was explanted from a female patient's right eye due to a broken haptic.Through follow up it was confirmed that the lens was implanted on (b)(6) 2017 and the physician was hoping that the lens would settle in the eye.However during a post-op visit, the physician noticed that the haptic was damaged and proceeded to explant the lens on (b)(6) 2017.No further information was available.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 02/14/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Device inspection was performed and visual inspection with the unaided eye shows that the product is damaged, most probably to make explant possible.The lens was inspected and showed the lens was cut up and one of the haptics was missing.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.Considering the condition of the lens additional analysis is not possible.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar 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: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6347518
• Report Number: 9614546-2017-00122
• Device Sequence Number: 16323750
• Product Code: HQL
• UDI-Device Identifier: 05050474552722
• UDI-Public: (01)05050474552722(17)190924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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: 09/24/2019
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 04/10/2017
• 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: 1MTEC30 LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR