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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2017.If explanted, give date: not applicable, an explant is scheduled for (b)(6) 2017.Planned explant.Very hyperopic.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct225 17.5 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.Post-operatively, the patient has reportedly become very hyperopic and needs to have a lens exchange.A planned explant is scheduled to be performed on (b)(6) 2017.The replacement lens is not known yet.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received reported that the planned explant was not done because the patient felt better.No additional information was provided.Device evaluation: the product was not returned to the manufacturing site as it remains implanted.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 johnson and johnson surgical vision has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6950538
• Report Number: 9614546-2017-00974
• Device Sequence Number: 11068211
• Product Code: HQL
• UDI-Device Identifier: 05050474552685
• UDI-Public: (01)05050474552685(17)210508
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/08/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 10/14/2017
• Supplement Report FDA Received Date: 02/28/2018
• 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