MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Code	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
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a za9003 12.0 diopter intraocular lens (iol) was implanted in the patient's operative eye.It was later explanted due to anisometropia, which led to aniscoria.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the za9003 +12.0 diopter intraocular lens (iol) was implanted in the right eye of the female patient on (b)(6) 2017.The lens was later explanted and replaced with another lens, same model higher diopter (+15.5).The incision was not enlarged to remove the lens and no other medical or surgical interventions were required.Also the name of the surgeon was provided.Sex/gender: female.If implanted, give date: (b)(6) 2017.Device available for evaluation? yes, returned to manufacturer on: 02/27/2018.(b)(6).Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens was cut in two pieces, which could be related to the explant process.Lubricant material residue and loose particles were observed on the lens surface.Both haptics were observed in good condition.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 revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7287879
• Report Number: 2648035-2018-00282
• Device Sequence Number: 1316917
• Product Code: HQL
• UDI-Device Identifier: 05050474528857
• UDI-Public: (01)05050474528857(17)211102
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 11/02/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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