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

Model Number PCB00

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable no patient contact reported.If explanted, give date: not applicable no patient contact reported.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the cartridge tip of a preloaded delivery system (model pcb00) was noticed bent prior to patient contact.Reportedly, the surgeon did not want to use it.No patient consequences were reported.Another pcb00 device was used to finish the case.No further information was provided.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on 08/23/2017.Device returned to manufacturer?: yes.Device evaluation: the device was returned to the manufacturing site for evaluation.The plunger was observed advance and locked.No viscoelastic residue was observed inside the cartridge.No molding, coating, and/or assembly issue were observed.Visual inspection was performed at 10x microscope magnification.The lens was observed stuck at the cartridge tip and the cartridge tip was observed smashed.Even though the complaint was confirmed, a cause of failure cannot be determined since the device was handled and the records reviewed were correct and the device has a protector cap on the cartridge.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6719907
• MDR Text Key: 80258528
• Report Number: 2648035-2017-01280
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558311
• UDI-Public: (01)05050474558311(17)191207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/07/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1