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

Model Number PCB00

Device Problems Bent (1059); Difficult to Remove (1528); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

There is no indication that the lens was explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) was inserted into the patient's eye and it unfolded normally.When the surgeon tried to pull the injector out of the eye, the tip of injector got caught in the phaco incision.Strong manipulation and the use of the viscoelastic healon was required to free the injector.The tip of the injector (plunger) was noticed bent like a barb.Reportedly, it was also noticed a scratch on the lens.No patient injury was reported.Patient pre-operation od (ocular dexter - right eye) 0.4, os (ocular sinister - left eye) 0.64.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 02/02/2017.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residue of viscoelastics at the cartridge tip.Heavy stress marks were observed at the cartridge tip which are typically caused by the pass of the iol through the cartridge.The push rod tip was observed bent.The intraocular lens (iol) was not returned as it remained implanted in the patient's eye.A photo of the implant was provided and it was evaluated.No scratches were observed.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.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.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: 6306307
• MDR Text Key: 66669618
• Report Number: 2648035-2017-00220
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)191130
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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
• Patient Age: 89 YR