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

Model Number PCB00

Device Problems Difficult to Insert (1316); Defective Device (2588)

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

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted, give date: na (not applicable) as it was indicated the lens was partially delivered into the eye and not fully implanted.If explanted, give date: na (not applicable) as it was indicated the lens was partially delivered into the eye and not fully implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the intraocular lens (iol) touched the patient but the procedure was incomplete.Additional communication on (b)(6) 2015 clarified that the event was an incomplete insertion and the pcb00 was defective.No patient injury reported.No further information is available.

Manufacturer Narrative

The pcb00 delivery system was received at the manufacturing site for investigation.Visual inspection, using a microscope at 10x magnification, showed scarce ovd (ophthalmic viscoelastic) residue inside the cartridge.The plunger was observed loaded as required and engaged.The cartridge was observed in the correct position, fully engaged into the lower body of the pcb00 delivery system.No damage was observed.The delivery system was received; however, there was no intraocular lens (iol) inside the system.The customer's reported event could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The manufacturing process record was evaluated.The product was manufactured and released according to specification.A search revealed that no other similar complaints for this order number have been received.Labeling review: 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 not verified.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5331141
• MDR Text Key: 35035400
• Report Number: 2648035-2015-01401
• Device Sequence Number: 1
• Product Code: HQL
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

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
• Device Operator: Physician
• Device Expiration Date: 02/13/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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