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

Model Number PCB00

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the customer experienced an issue with a preloaded insertion system as the lens exited the introducer too early.In follow-up, it was reported that there was no problem in locking the handle/plunger/inserter and the plunger had actually torn into the left hand side of the introducer.The lens sat in the wound and the surgeon removed and discarded the lens.No further information was provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 09/18/2015.Device evaluation: the preloaded insertion system was returned to manufacturing site for evaluation.The intraocular lens (iol) was not returned.Visual inspection showed the cartridge was observed fully engaged into lower body of the pcb00 device.The plunger component was observed in a fully advanced position.No assembly error was observed.Visual inspection at 10x microscope magnification verified no lens was observed in the pcb00 device.No damages in the plunger or rod tip were observed.Viscoelastic (ovd) residues were observed at the cartridge tube/tip.Stress marks in both sides of the cartridge tube and tip was observed, which are typically caused and/or may well appear by the passing of the iol thru the cartridge.There is no evidence to suggest any fault on the pcb00 preload insertion system that could lead to the reported issue.The investigation results do not suggest that the complaint sample has been affected by the manufacturing process.A manufacturing record review was performed.The manufacturing process record was evaluated and the lenses were manufactured within specifications.The units were released according to specification.No potential product deficiencies were identified.No other complaints for this production order (po) were received.In addition the directions for use (dfu) were reviewed.The dfu adequately provides the customer with information on precautions and proper device usage.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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 5072992
• MDR Text Key: 25614884
• Report Number: 2648035-2015-00789
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 11/24/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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