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 Codes	Irritation (1941); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of event was not provided.It is noted the symptoms began almost immediately after implantation of the lens on (b)(6) 2015.The lens remains implanted all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a male patient experienced terrible halos (bright circles that appear to surround a source of light) around car lights, lamp posts, lit signs at night which make driving at night unsafe and irritating.He has been experiencing these symptoms almost immediately after implantation of a zlb00 multifocal lens.In follow up with the surgery center it was asked if there was anything in the patient's chart attributing the patient's visual issues to the lens.The response was that nothing was found about it.No additional information was provided.
Additional Manufacturer Narrative
The product testing was not performed as the complaint device was not returned for analysis; the intraocular lens remains implanted.The reported complaint cannot be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the manufacturing record review, historical review and non-conformance review, there is no indication of a product deficiency.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: 5947812
• Report Number: 9614546-2016-00456
• Device Sequence Number: 605234
• Product Code: MFK
• UDI-Device Identifier: 05050474560550
• UDI-Public: (01)05050474560550(17)190420
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2016

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: 04/20/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/03/2016
• 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: Other