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

Model Number	PCB00
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that the cartridge split during handling but prior to insertion.During follow up, the customer confirmed that as the technician was trying to move the intraocular lens (iol) out, the cartridge split at the tip.There was no patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/12/2017.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 advanced position and the cartridge correctly engaged into lower body of the pcb00 device.No assembly errors and/or defects related to manufacturing process were observed.Visual inspection at 10x microscope magnification showed that the cartridge tip and tube were cracked.The lens was received out of the insertion device.The customer's reported complaint was verified manufacturing records review: the manufacturing records for the intraocular lens were reviewed.During manufacturing the operators inspect 100% all cartridges using a microscope at 10x magnification.Operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.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: 6682856
• Report Number: 2648035-2017-01194
• Device Sequence Number: 11163257
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)181207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/07/2017

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: 12/07/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1