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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2015.Explant date: if explanted, give date: not applicable as the lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zma00 20.5 diopter intraocular lens (iol) was implanted into the right eye (od) on (b)(6) 2010.Reportedly, since 2015, the patient has experienced a 50% decline in her vision in the right eye.She has also experienced very bad headaches, floaters, and at times weeping and dry eyes.The patient has gone to eye doctors to get the matter resolved, but with very little success.In follow up with the implanting physician's office it was learned the patient's last appointment with her surgeon was (b)(6) 2017, her best corrected visual acuity (bcva) was 20/30+ in both eyes (ou).The contact provided the implant dates of both lenses and product identifiers.In addition, per the patient's records at the surgeon's office there is no need for any additional treatment and follow-up will be done after 6 months.The surgeon did not refer the patient to see a secondary doctor.The patient reported seeing a secondary physician and was told they may need to remove the lens and the patient reportedly had a follow up appointment with this doctor on (b)(6) 2017.In follow up with this secondary physician's office it was learned the patient was seen for a totally different issue that wasn't related to the iols and it was stated that no further information could be provided.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's right eye.A separate report will be filed for the left eye.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7047627
• Report Number: 9614546-2017-01140
• Device Sequence Number: 1916031
• Product Code: MFK
• UDI-Device Identifier: 05050474536814
• UDI-Public: (01)05050474536814(17)140308
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/08/2014
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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: Other