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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct300 17.5 diopter intraocular lens (iol) that was implanted in the left eye (os) on (b)(6) 2017 rotated 10 degrees at the 6-month doctor visit.It was reported that no repositioning or further intervention is required.The protocol-defined slit lamp measurement was 91 degrees on (b)(6) 2017 versus the operative placement of 81 degrees (b)(6) 2017.Reportedly the patient is doing well and there are no outcomes that affect daily activities.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 92705
• MDR Report Key: 6901629
• Report Number: 9614546-2017-00934
• Device Sequence Number: 538367
• Product Code: HQL
• UDI-Device Identifier: 05050474553279
• UDI-Public: (01)05050474553279(17)190807
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/07/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR