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

Model Number	PCB00
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not fully implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation, an intraocular lens (iol) would not advance out of the cartridge.Reportedly, the tip of cartridge touched the patient's eye and the edge of the lens was in the eye.The incision was not enlarged to remove the lens, no sutures were used and no vitrectomy was performed.Another lens with the same diopter was implanted without difficulties.The patient status was reported as stable.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/28/2017.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.The plunger and pushrod were observed in advanced position.No assembly errors and/or defects were observed related to the manufacturing process.Visual inspection at 10x microscope magnification showed residue of viscoelastic solution on the cartridge.One part of the intraocular lens (iol) was returned out of the preloaded system, and it was observed torn.Loose fibers/particles were observed on the lens.The other part of the lens was observed exposed at the cartridge tip.The conditions of the lens returned was consistent with a unit that was handled and prepared for surgical process.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 investigation requests 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 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: 6704500
• Report Number: 2648035-2017-01257
• Device Sequence Number: 16660322
• Product Code: HQL
• UDI-Device Identifier: 05050474558106
• UDI-Public: (01)05050474558106(17)190910
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 09/10/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1