MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)
Date of Event	01/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) would not position correctly in the eye.Reportedly the lens was cut out of the eye.An undefined patient intervention/injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was reported that there was no patient injury.The intraocular lens (iol) was removed and replaced during the same surgical procedure.There was no vitrectomy performed and no complications.The patient was reported doing well.This event has now been determined not to be a reportable event.(b)(4).No further reports will be sent for this file.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6347814
• Report Number: 2648035-2017-00339
• Device Sequence Number: 720389
• Product Code: HQL
• UDI-Device Identifier: 05050474531918
• UDI-Public: (01)05050474531918(17)170216
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/16/2017
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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: Required Intervention