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	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or 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 during the insertion of an intraocular lens (iol) into the patient's eye, the lens got stuck in the cartridge.The tip of the cartridge was in the incision and the front part of the lens had patient contact too.Reportedly, the lens came back out of the eye when the cartridge was removed from the incision.No incision enlargement, no sutures were used and no vitrectomy was performed.The patient left the operating room in stable condition.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 11/30/2017.Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.The plunger was observed in advanced position, and locked; the cartridge was correctly engaged into lower body of the pcb00 device.No assembly error and/or defect related to the manufacturing process were observed.Visual inspection at 10x microscope magnification showed lack of lubricant material in the device.The intraocular lens (iol) was observed stuck at the cartridge tip and one of the haptic was exposed out of the cartridge.The reported customer's complaint for stuck in cartridge was verified.However, the condition in which the sample was returned is consistent with a product that was handled and prepared for surgical 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) 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: 6939297
• Report Number: 2648035-2017-01854
• Device Sequence Number: 10942248
• Product Code: HQL
• UDI-Device Identifier: 05050474558113
• UDI-Public: (01)05050474558113(17)200310
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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: 03/10/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1