MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).If explanted, give date: not applicable as the lens remains implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after an intraocular lens (iol) was inserted into the patient's eye, a piece of plastic was noticed on top of the lens.Reportedly, the plastic was removed from the eye.The account commented that they don't know if the plastic was coming from the lens or the unfolder (cartridge).Additional information was received and it was learnt that the lens was left in the patient's eye.No incision enlargement, no vitrectomy was performed and no sutures were used.The patient was reported being fine.This mdr is to record the lens.A separate report will be filed for the cartridge.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 10/20/2017.Device evaluation: a vial containing a small piece of apparent plastic was returned at the manufacturing site for evaluation.The small piece of plastic was analysed using the fourier transform infrared (ftir) spectroscopy.The results revealed that the particle was consistent with coatings of adhesive from transport and sodium hyaluronate while the bulk was consistent with polypropylene.The intraocular lens was not returned as to date it remains implanted.Based on the investigation, it was not possible to confirm if the particle was related to manufacturing, as the lens was handled and prepared for surgical procedure.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.During manufacturing the operators clean and visually inspect the lenses 100% at 10x microscope magnification.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.In addition sterilization records were reviewed: sterilization was processed and no deviations were found that affects the sterility of the device.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 could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6894752
• Report Number: 2648035-2017-01704
• Device Sequence Number: 659273
• Product Code: HQL
• UDI-Device Identifier: 05050474531499
• UDI-Public: (01)05050474531499(17)190313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 03/13/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1