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

Model Number	ZCT400
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An attempt has 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 zct400 16.5 diopter intraocular lens (iol) was implanted on (b)(6) 2017.The lens was later explanted on (b)(6) 2017, to change the diopter size and because the lens rotated.The lens was discarded.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the lens rotated 30 degrees.Also, the lens was replaced with a zct600 16.5 diopter intraocular lens (iol).The patient needed a higher diopter lens.There was no incision enlargement, vitrectomy, or complications reported.The patient is reportedly happy.No additional information was reported.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Correction: the device evaluation should have been captured and reported in the supplemental mdr, however, it was inadvertently not provided.The following information has been provided.Device evaluation: the product was not returned to the manufacturing site.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 product was 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: 6833128
• Report Number: 9614546-2017-00821
• Device Sequence Number: 16524503
• Product Code: MFK
• UDI-Device Identifier: 05050474553842
• UDI-Public: (01)05050474553842(17)210419
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2017

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?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 11/17/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/09/2017; 12/15/2017
• 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