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	08/16/2017
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.Device evaluation: the product was returned for evaluation.The plunger was observed in the advanced position.The cartridge was correctly engaged into the device.No assembly error related to the manufacturing process was observed.The lens was observed stuck at the cartridge tip.The push rod was seen to override the lens and protrude through to the side of the cartridge tip, creating a cartridge crack.The reported issue was verified.However, the condition observed is consistent with a unit that was handled and prepared for surgical use.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the cartridge split when forwarding the preloaded delivery system.There was no patient involvement/injury reported.During follow up, it was confirmed that the end/tip of the cartridge split as the surgeon was about to implant.The surgeon stopped once he saw the split to prevent patient injury.No additional information was provided to abbott medical optics.

• 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: 6855887
• Report Number: 2648035-2017-01626
• Device Sequence Number: 801142
• Product Code: HQL
• UDI-Device Identifier: 05050474558069
• UDI-Public: (01)05050474558069(17)200420
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/11/2017

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: 04/20/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1