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

Model Number	ZLB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a a zlb00 8.0 diopter (d) intraocular lens (iol) was explanted due to patient experiencing severe distorted vision following the cataract surgery.The lens was replaced with the same model lens with a 9.5 diopter.The was no incision enlargement or vitrectomy required.There was no patient injury reported.Through follow up it was confirmed physician preformed the iol exchange due to a miscalculation and overcorrection of the iol power.Additionally, it was learned that the patient's refraction was +1.25 best corrected 20/60 after the zlb00 8.0 d iol was implanted.Prior to surgery patient's left eye (os) was best corrected 20/25 with -8.25 sphere (sph).
Additional Manufacturer Narrative
Corrected data: upon further review of the report, it was observed that the evaluation code (b)(4) provided in the initial report should have been (b)(4).Furthermore, method code (b)(4) is now updated to (b)(4) as the device has been received and evaluated.Additionally, a summary for the manufacturing record review and labeling review (method and result codes) was inadvertently not included in the initial mdr.The summary for the coding is being provided in this supplement.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Additional information: device available for evaluation ¿ yes, returned to manufacturer on 03/23/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.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 issue could not be confirmed in the returned sample.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
Corrected data: upon further review, it was identified that evaluation codes and additional mfr narrative in the initial report contained incorrect information.(b)(4) enlargement was inadvertently reported.This report is to clarify that for this event, incision enlargement was not required.All pertinent information available to the manufacturer 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: 6450446
• Report Number: 9614546-2017-00259
• Device Sequence Number: 567239
• Product Code: MFK
• UDI-Device Identifier: 05050474560437
• UDI-Public: (01)05050474560437(17)200614
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2017

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: 06/14/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/18/2017; 06/15/2017
• 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: Required Intervention
• Patient Age: 64 YR