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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 zmb00 18.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6)2014.The patient complained that immediately after the implantation she had floaters, blurriness, and halos.Reportedly, the patient went back to the doctor who then performed laser in both her eyes, which resolved the floaters.However, the blurriness and halos are still present.Also, the patient complains that she constantly must blink while driving just to see and does not drive at night any longer due to the halos.In follow up it was learned that the patient has been going back and forth to doctor for follow-up but to no avail.Last follow-up was when the doctor did laser which helped but only with the floaters.The blurriness, halos/glares are still present.The right eye is not as bad as the left eye but both are experiencing the same thing.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
Additional information received reported that the last time the patient saw the doctor was 2016 and at that time the patient did not have any concerns about her intraocular lenses.Also, the patient was advised to come back for a one year follow up, but did not show up and has not come back.No additional information was provided.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 have been 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.
Additional Manufacturer Narrative
Correction: in the mdr follow up #1, the date was incorrectly left blank.The correct date that should have been entered into the field is (b)(6) 2017.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 92705
• MDR Report Key: 6950658
• Report Number: 9614546-2017-00980
• Device Sequence Number: 1112176
• Product Code: MFK
• UDI-Device Identifier: 05050474535596
• UDI-Public: (01)05050474535596(17)180316
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2017

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: 03/16/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 11/13/2017; 12/12/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/11/2017; 12/12/2017
• 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