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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Per the surgeon, there was a lot of pressure when attempting to advance the intraocular lens (iol) and the plunger split the distal end of the cartridge.No patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 10/27/2016.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system was returned at the manufacturer for evaluation.Visual inspection at 10x microscope magnification showed residues of what appears to be viscoelastics in the cartridge.Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the lens through the cartridge.The cartridge's tip was observed deformed.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.

• 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: 6019058
• Report Number: 2648035-2016-01576
• Device Sequence Number: 1916935
• Product Code: HQL
• UDI-Device Identifier: 05050474558045
• UDI-Public: (01)05050474558045(17)181209
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2016

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: 12/09/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 11/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1