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

Model Number	PCB00
Medical Device Problem Codes	Detachment Of Device Component (1104); Torn Material (3024); Device Handling Problem (3265)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable) as the lens was inserted and removed.If explanted; give date: n/a (not applicable) as the lens was inserted and removed.(b)(6).(b)(4).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 and the cartridge was correctly engaged into lower body of the pcb00 device.The intraocular lens (iol) was also returned (outside of the insertion device).Visual inspection at 10x microscope magnification showed that the lens was broken into pieces due to the explant process, as reported by the customer.One haptic was observed detached.The customer's reported complaint was 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 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.
Event or Problem Description
It was reported that the haptic of an intraocular lens (iol) tore off during implantation.No patient injury was reported.Additional information was received and it was learnt that the lens was removed and replaced during the same surgical procedure and the incision was enlarged.Reportedly, the surgeon was blaming himself because he noticed a resistance in the advancement of the lens, but he implanted the lens anyway and the haptic was torn off.No further information was provided.

• 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: 6483944
• Report Number: 2648035-2017-00665
• Device Sequence Number: 1198879
• Product Code: HQL
• UDI-Device Identifier: 05050474558076
• UDI-Public: (01)05050474558076(17)170910
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/10/2017
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention