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

Model Number	ZLB00
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2017.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 13.0 diopter intraocular lens (iol) was implanted on (b)(6) 2017, and later explanted on (b)(6) 2017.The lens was replaced with a model, zxr00, a larger 16.0 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the reason for explant was due to a post-operative refractive error caused by the lens dislocating.Also, the patient complained of blurry vision that interfered with distance and near vision.Furthermore, the patient was a male, date of birth (b)(6) 1955, and the operative eye was the right eye.Reportedly, there was no incision enlargement, vitrectomy, or sutures used.Also, there was no patient injury.No additional information was provided.The following sections were updated based on the additional information received: age/date of birth: (b)(6) 1955.Gender/sex: male.Updated to both adverse event and product problem.(b)(4).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.
Additional Manufacturer Narrative
Device evaluation: the product was received in a lens case.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens, additional analysis is not possible.The reported complaint cannot be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.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: 6885252
• Report Number: 9614546-2017-00907
• Device Sequence Number: 11065178
• Product Code: MFK
• UDI-Device Identifier: 05050474560536
• UDI-Public: (01)05050474560536(17)200915
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/29/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/15/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 09/22/2017; 02/09/2018; 06/11/2018
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/17/2017; 03/09/2018; 06/29/2018
• 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