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

Model Number	ZKB00
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant planned for (b)(6) 2017 but not confirmed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the patient had zkb00 intraocular lenses (iols) implanted into both eyes (ou) since she wanted to read near having been myopic (-4.50).There was no reported issues with the left eye.The right eye, which had a zkb00 17.0 diopter, came out with a refractive surprise of +1.00 +0.25 x 75 post-operatively.The patient is reportedly not happy and an explant was performed on (b)(6) 2017 due to poor visual results.The lens was replaced with the same model, but different diopter.No additional information was provided.
Additional Manufacturer Narrative
Returned to manufacturer on: 01/05/2018.Device returned to manufacturer: yes.The product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in half, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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
Additional information received reported the implant date was (b)(6) 2017, and the explant date was (b)(6) 2017.The operative eye was the right eye and the explant was due to a refractive surprise.Reportedly, there were no other visual issues.There was no incision enlargement, vitrectomy, or capsule tear.The replacement lens was the same model, but different diopter of 18.5.The patient is doing very well post-operatively.No additional information was provided.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6829453
• Report Number: 9614546-2017-00820
• Device Sequence Number: 16521855
• Product Code: MFK
• UDI-Device Identifier: 05050474560024
• UDI-Public: (01)05050474560024(17)200209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2018

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: 02/09/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 11/14/2017; 12/05/2017; 01/18/2018
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 12/12/2017; 01/03/2018; 02/14/2018
• 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: Other
• Patient Age: 58 YR