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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a female patient was implanted with a zkb00 lens in both eyes.After implantation of a zkb00 24.0 diopter intraocular lens (iol) in her left eye, the patient experienced visual disturbance issues, halos/glare and intolerance with her zkb00.There is no plan to explant because the patient does not want the lens explanted.It was also reported that the patient only had issues with the left lens.Patient did not experience any issues with the lens that was implanted on (b)(6) 2016 (right eye).No further information was provided.
Additional Manufacturer Narrative
Additional information received reported the patient's date of birth is (b)(6).Also, the patient's condition remains the same and there is no intention of further surgery at this point.No additional information was provided.Age/date of birth: (b)(6).Device evaluation: the intraocular lens (iol) 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 intraocular lens were 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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6742801
• Report Number: 9614546-2017-00667
• Device Sequence Number: 13666763
• Product Code: HQL
• UDI-Device Identifier: 05050474560161
• UDI-Public: (01)05050474560161(17)191201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: 12/01/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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