MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/02/2016
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 a zlb00 intraocular lens (iol) was implanted and then removed after the doctor discovered a compromise in the capsular bag.A model zma00 lens was subsequently implanted.No patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional info: additional information was received and it was reported that there was no product quality issue.The circumstances to change lenses was due to the patient's eye condition.The event has now been determined not to be a reportable event.No further reports will be sent for this file.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5912595
• Report Number: 9614546-2016-00423
• Device Sequence Number: 13541171
• Product Code: MFK
• UDI-Device Identifier: 05050474560604
• UDI-Public: (01)05050474560604(17)181127
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2016

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: 11/27/2018
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 09/23/2016
• 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