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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: n/a as the lens was inserted and removed.Concomitant medical products: bss (balance salt solution), lot unknown; viscoelastic model and lot number unknown.Initial reporter phone number: (b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that immediately after the implantation of an intraocular lens (iol) a defect, a little missing piece, was noticed in the middle of the optic.The lens was cut in two parts and removed and replaced with another pcb00, same diopter, during the same surgical procedure.The missing little piece was also removed from the eye.Reportedly, the lens loading was performed according to the standard procedure using bss (balance salt solution) and viscoelastic.There were about 10 minutes delay in the procedure.No incision enlargement was reported.No problems were found one day post-op.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 04/17/2017.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.The plunger was observed in a fully advanced position.The cartridge was observed correctly engaged into the lower body of the pcb00 device.Visual inspection at 10x microscope magnification showed that the lens was cut in two pieces, most probably to make explant/removal possible.Photos of the implant, prior to the removal from the eye, were provided and were evaluated.It was not possible to discern what the abnormality was or where it was located in the lens (on the surface or within the substance of the lens).Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.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 was verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6443384
• Report Number: 2648035-2017-00580
• Device Sequence Number: 501053
• Product Code: HQL
• UDI-Device Identifier: 05050474558137
• UDI-Public: (01)05050474558137(17)191119
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2017

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: 11/19/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR