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	Visual Disturbances (2140); No Code Available (3191)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 intraocular lens (iol) was explanted from a female patient's right eye (od) due to intractable glare and poor quality of vision.It was stated that both eyes (ou) were effected, however; as of now they have only explanted the right eye.The doctor is hoping with exchanging of the patient's dominant eye's iol, perhaps they can avoid the left eye implant removal.There was no sutures or vitrectomy required.There was slight wound enlargement to accommodate iol which was folded intra-camerally.There was no post-op incident reported.
Additional Manufacturer Narrative
A product evaluation/testing was not performed as no product was returned.The complaint cannot be confirmed.Manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production 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 investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Additional information received reported the patient still isn't so happy with the outcome, but it's better than before.Also, the second intraocular lens has not been explanted.No additional information was provided.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: 6769515
• Report Number: 9614546-2017-00705
• Device Sequence Number: 1508987
• Product Code: MFK
• UDI-Device Identifier: 05050474560673
• UDI-Public: (01)05050474560673(17)200113
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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,Followup
• Report Date (Section B): 01/17/2018

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: 01/13/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 12/21/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 11/30/2017; 01/17/2018
• 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: 58 YR