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

Model Number	ZCT400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt age/date of birth: unknown/ not provided.Date of event: unknown/not provided.Implant date: if implanted; give date: unknown/not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a model zct400 intraocular lens (iol) dislocated post implant.The exact date of the dislocation is unknown.The lens was explanted from the male patient's eye and replaced with a different iol.There was no incision enlargement and no vitrectomy.There were no complications.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 10/21/2016.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and the lens was visually inspected with an unaided eye.The product was observed cut in half, most probably to make explant possible.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.Based on the investigation results there is no indication of 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: 5989085
• Report Number: 9614546-2016-00486
• Device Sequence Number: 10989457
• Product Code: HQL
• UDI-Device Identifier: 05050474553927
• UDI-Public: (01)05050474553927(17)181006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2016

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: 10/06/2018
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 12/12/2016
• 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