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

Model Number PCB00

Device Problems Difficult or Delayed Positioning (1157); Delivery System Failure (2905); Difficult to Advance (2920)

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

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lens remains implanted at the time of submitting the mdr.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that at the time of insertion of the intraocular lens (iol) in the capsular bag of the patient's eye, the injector in the second black line is given the "click" and the screw rolled false.The physician returned the plunger rod trying to hear the "click", but without success.The lens was removed from the injector, inspected and the physician did not identify any damage to the iol.The surgeon asked for a new 1mtec cartridge and conclude the surgery successfully.Reportedly, just the bevel of the injector had contacted the patient's eye.The patient did not have any problem after the surgery.There was no corneal edema or other injury to the patient.No further information was provided.

Manufacturer Narrative

The preloaded insertion system was returned to the manufacturer for evaluation.Visual inspection of the return sample revealed that the cartridge was received fully engaged into the lower body of the preloaded device.The plunger component was observed in a fully advanced position.The preloaded insertion system was visually inspected under a microscope.No lens was observed inside the preloaded device as it was stated in the initial report that the lens was removed from the injector and 1mtec30 cartridge was used to conclude the surgery.The lens remains implanted in the patient.The reported complaint cannot be confirmed.A review of the directions for use (dfu) was conducted.The dfu adequately provides instructions and precautions for the proper use and handling of the device.The manufacturing record review was performed.The lenses were manufactured within specifications.The units were released according to specification.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: 5084669
• MDR Text Key: 26071259
• Report Number: 2648035-2015-00816
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2017
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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