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

Model Number	ZCT150
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: not applicable as the lens was removed and replaced within the same procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was removed and replaced as the haptic tore the capsule bag.Further information reported the event occurred due to loading error with the lens.The lens was replaced within the same procedure.No further information was provided.
Additional Manufacturer Narrative
Further follow up provided reports that the lens was replaced with a model z9002 lens.The patient was reported in good condition post-op.No further information was provided.Device available for evaluation?: yes, returned to manufacturer on 08/07/2017.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye showed the product is cut in pieces, most probably to make remove and replacement possible.Considering the condition of the lens additional analysis is not possible.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 were 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: 6655451
• Report Number: 9614546-2017-00549
• Device Sequence Number: 1149623
• Product Code: HQL
• UDI-Device Identifier: 05050474552142
• UDI-Public: (01)05050474552142(17)200510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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: 05/10/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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