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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the trailing haptic of a za9003 25.0 diopter intraocular lens (iol) was noticed severed during implantation into the patient's right eye (od).Reportedly, the lens was mostly inserted into the patient's eye.The lens was removed and it was reported that the leading haptic popped off during the removal of the lens.There was reportedly an incision enlargement performed.The lens was replaced with the same model and diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed.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 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.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7043228
• Report Number: 2648035-2017-02117
• Device Sequence Number: 1423966
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)220629
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 06/29/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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
• Patient Age: 76 YR