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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted in a secondary surgical procedure from the left eye of a (b)(6) female patient because of complications of the iol, blurred vision.Reportedly, the lens was replaced with another lens, same model smaller diopter (+17.5).No further information was provided.
Additional Manufacturer Narrative
During a follow up, the customer stated that there were no complications such as vitrectomy and wound enlargement and the lens was exchanged as the patient was unable to see with the original implanted lens.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
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 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
• MDR Report Key: 6459634
• Report Number: 9614546-2017-00272
• Device Sequence Number: 10903567
• Product Code: HQL
• UDI-Device Identifier: 05050474553323
• UDI-Public: (01)05050474553323(17)200531
• 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
• 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): 11/14/2017

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: 05/31/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 10/17/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 09/23/2017; 11/14/2017
• 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: 62 YR