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

Model Number	ZCT225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during insertion into the eye the haptic broke off.There was patient contact and reportedly an adverse effect, injury or surgical intervention was required.No further details were provided.
Additional Manufacturer Narrative
Additional information: through follow up clarification and further information regarding the reported event was provided by the complaint reporter.The haptic broke off during insertion.It may have been distorted during loading; however, it was coming out of the cartridge just fine.As the haptics started to unfold, the back haptic floated away from the optic and was detached prior to manipulation.The lens had patient contact.It was fully implanted.The lens was removed and replaced with a back-up lens during the same procedure.No incision enlargement necessary.The patient is doing great.(b)(4).Note: based on the clarification/additional information received from the customer, this event no longer meets mdr reportability criteria.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6277153
• Report Number: 9614546-2017-00048
• Device Sequence Number: 393607
• Product Code: HQL
• UDI-Device Identifier: 05050474552722
• UDI-Public: (01)05050474552722(17)190126
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/20/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/26/2019
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 02/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention