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	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Visual 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.There were no non-conformances with respect to the manufacturing process.There are no associated nonconformity reports or deviations.The product was manufactured according to specification.A search revealed no other complaints for this production order number has been received.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 abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct150 16.5 diopter intraocular lens was explanted from the patient's right eye due to the lens rotating 35 degrees, even with a ctr (capsular tension ring).No patient post-op injury was reported.The lens and the ctr will not be returned.The lens was explanted and replaced with a zct150 14.0 (smaller) diopter intraocular lens in the right eye.No other information was provided.
Additional Manufacturer Narrative
Additional information: the initial report indicated that the (capsular tension ring) ctr was in place with the lens.The customer stated that the lens was explanted and that both ctr and lens would not be returned.Through follow-up it was clarified that the ctr used in this event remains implanted.The customer reported that there was nothing wrong with the ctr.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6064328
• Report Number: 9614546-2016-00557
• Device Sequence Number: 16230346
• Product Code: HQL
• UDI-Device Identifier: 05050474552074
• UDI-Public: (01)05050474552074(17)200412
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2016

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: 04/12/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 11/30/2016
• 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: CTR STBL13US SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR