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

Model Number	ZMA00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Blurred Vision (2137); Halo (2227)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zma00 20.0 diopter intraocular lens (iol) was explanted from a female patent's right eye (od) due to a subluxation of the lens.Through follow up it was confirmed that the patient was experiencing subluxation of the lens od (decentered superotemporal).Patient also experience pain, foreign body sensation, blurry vision, light sensitivity and halos on her right eye.These issues have affected her daily activities.Visual acuity right eye: sc 20/50 (sans corrected) ph 20/40 (pin hole).Visual acuity left eye: sc 20/50 phni (pin hole no improvement).
Additional Manufacturer Narrative
Additional information: through follow up, it was reported that the replacement lens was a monofocal lens.Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and there were no related nonconformity reports.The product was manufactured and released according to specifications.A search on complaints revealed no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6382491
• Report Number: 9614546-2017-00166
• Device Sequence Number: 16281800
• Product Code: MFK
• UDI-Device Identifier: 05050474536807
• UDI-Public: (01)05050474536807(17)190617
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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: 06/17/2019
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 04/14/2017
• 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
• Patient Age: 67 YR