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

Model Number	ZMB00
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The surgeon had difficulty inserting the intraocular lens (iol) into the patient's eye and had to enlarge the incision to take the iol out and insert a new one.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned; however, the empty lens case was received.Therefore, an investigation was not possible and the reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The manufacturing process was evaluated and the lenses were manufactured within specifications.The units were released according to specification.No non-conformance reports, related to the reported event, were identified during the review.A search on complaints revealed no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the intraocular lenses.Based on the investigation results, no product deficiency was identified.The customer's reported event could not be confirmed.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: 5931542
• Report Number: 2648035-2016-01392
• Device Sequence Number: 16287953
• Product Code: MFK
• UDI-Device Identifier: 05050474535619
• UDI-Public: (01)05050474535619(17)170115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/06/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2017
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2016
• Supplement Report FDA Received Date: 10/06/2016
• 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