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

Model Number	ZA9003
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a scratch was noticed on an intraocular lens (iol), once inserted into the patient's eye.Reportedly, the lens was removed.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/13/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site cut in pieces.Visual inspection under the microscope showed that the lens pieces had particles, scratches and viscoelastic residue.This condition is typical of a lens that was removed during the surgical procedure.The customer's reported complaint was verified however due to the condition of the lens, the damage could not be associated to the manufacturing process.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) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information received reported that the lens was inserted and removed during the same procedure.The lens was replaced with the same model za9003, but different diopter of 15.0.Reportedly, the diopter changed from a 14.5 to a 15.0 because they did not have another 14.5 diopter in stock.There was no incision enlargement, vitrectomy, or sutures used.No additional information was provided.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6659449
• Report Number: 2648035-2017-01119
• Device Sequence Number: 220412
• Product Code: HQL
• UDI-Device Identifier: 05050474528901
• UDI-Public: (01)05050474528901(17)210419
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/19/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 09/25/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/09/2017; 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE EMERALDC30, LOT UNKNOWN.