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

Model Number	PCB00
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defect was noticed prior to insertion of the lens into the eye which reasonably suggests the lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The intraocular lens was kinked/crimped.The lens was scrunched up when advanced, during handling but prior to insertion.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information: the customer confirmed that there was no patient contact and no incision enlargement or vitrectomy.The surgeon was able to complete the procedure with a backup intraocular lens without injuries.Device available for evaluation ? yes, returned to manufacturer on 02/01/2017.Device returned to manufacturer ? yes.Device evaluation: the intraocular lens (iol) unit was received in the original folding carton.The cartridge component was observed correctly engaged into the lower body of the device.The plunger component was observed in the advanced position.The plunger was gently pulled back, and it was found not locked.Visual inspection at 10x microscope magnification was performed.Residues of viscoelastics were observed on the cartridge of the returned device.The lens was observed stuck at the loading zone.The lens was torn.The reported issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.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.

• 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: 6213734
• Report Number: 2648035-2016-02104
• Device Sequence Number: 13533731
• Product Code: HQL
• UDI-Device Identifier: 05050474558472
• UDI-Public: (01)05050474558472(17)190524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/01/2017

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: 05/24/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1