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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	08/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient had to come back the same day ((b)(6) 2017) as the lens implanted, a zct400 16.5 diopter intraocular lens (iol) had rotated and had to be repositioned in a secondary procedure.Furthermore, the patient had to come back a separate day to have the lens explanted due to a large eye.Reportedly, the patient is doing fine.The lens was replaced with a model zct300 lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 07/07/2017.Device returned to manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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 were 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.
Additional Manufacturer Narrative
Additional information received reported that the intraocular lens (iol) would not stay in position and kept rotating out of position, which resulted in the patient's vision not being optimum.For this reason, the lens was explanted.It was also reported that the patient's date of birth was 06/15/1944 and the operative eye was the left eye (os).There was no incision enlargement, vitrectomy, or sutures used.Furthermore, the diopter of the replacement lens was 16.5.Age/date of birth: (b)(6).(b)(4).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: 6902373
• Report Number: 9614546-2017-00935
• Device Sequence Number: 483776
• Product Code: HQL
• UDI-Device Identifier: 05050474553842
• UDI-Public: (01)05050474553842(17)210419
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2017

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: 04/19/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 10/24/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 10/21/2017; 11/21/2017
• 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: 73 YR