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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Dizziness (2194)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date the lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that it has been over one (1) year that the patient has been having issues with both eyes.It was reported that a male patient has been suffering for over one (1) year.With one eye he can see very close and with the other eye he can only see far away and that he cannot read with either eyes.It was reported that the patient is unbalanced when he looks through both eyes.The patient visited his doctor and was given prescription glasses which has not help him at all.The patient has difficulty driving and gets dizzy as there is no balance.The patient saw another doctor who confirmed the first doctor¿s diagnosis, that he would need glasses.Both doctors informed the patient that there is no plan to explant the lenses.No further information was provided.This report pertains to patient's left eye (os).A separate report will be submitted for the patient's right eye (od).
Additional Manufacturer Narrative
Device evaluation the product testing was not performed as the complaint device was not returned for analysis; the intraocular lens remains implanted.The reported complaint cannot be verified.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 product 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 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: 6753226
• Report Number: 9614546-2017-00681
• Device Sequence Number: 18869462
• Product Code: HQL
• UDI-Device Identifier: 05050474552227
• UDI-Public: (01)05050474552227(17)170708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 07/08/2017
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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: Other