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

Model Number	ZCT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant of intraocular lens.Unexpected post operative refraction.Myopic astigmatism.Anisometropia.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct150 intraocular lens was explanted from a female patient's left eye.Physician noted that there were no complications during the original surgery.Original intended axis of the lens was 86 degrees; however post implant the iol is in the eye at 76 degrees, also noted was myopic refractive surprise.Symptoms were residual myopic astigmatism with anisometropia.The response to outcome significantly interferes with activities of daily life was yes.Post explant / current status indicates the patient has recovered.
Additional Manufacturer Narrative
Additional information: as a result of follow up it was learned the replacement lens was another zct150 intraocular lens of a lower diopter (20.5).Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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: 6224390
• Report Number: 9614546-2017-00002
• Device Sequence Number: 16323926
• Product Code: HQL
• UDI-Device Identifier: 05050474552241
• UDI-Public: (01)05050474552241(17)200615
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/23/2017

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: 06/15/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 04/24/2017
• 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
• Patient Age: 69 YR