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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
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 15.0 diopter intraocular lens (iol) was noticed rotated at the six month follow up visit with the doctor on (b)(6) 2017.The lens rotated from 100 degrees to 115 degrees post-operatively, which was a 15 degree change.The patient complained of moderate blurred vision at all distances.Reportedly, the patient complaint does not significantly interfere with activities of daily life.There was no patient complications or injury.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's right eye.A separate report will be filed for the left eye.
Additional Manufacturer Narrative
Corrected data: : if implanted, give date: in the initial report, the implant date (b)(6) 2016) was entered.Clarification on the date was provided and it was learned the actual date of implant for the right eye (od) was (b)(6) 2017.This follow up has the correct date of implant.Additional information: device evaluation: the product testing was not performed as the complaint device was not returned for analysis (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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 92705
• MDR Report Key: 7120010
• Report Number: 9614546-2017-01231
• Device Sequence Number: 1749841
• Product Code: HQL
• UDI-Device Identifier: 05050474553163
• UDI-Public: (01)05050474553163(17)210224
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: 02/24/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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: Other
• Patient Age: 62 YR