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

Model Number PCB00

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) got caught in the incision during implantation into the left eye of (b)(6) female patient.Reportedly, the lens had to be removed during the same surgical procedure.The incision was enlarged but no suture used, no vitrectomy and no patient injury was reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 03/23/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) and the preloaded delivery system, model pcb00, were returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens was returned out of the pcb00 device.Both lens haptics were observed in good condition and form.Evidence of viscoelastic residue, ovd (ophthalmic viscosurgical device) was observed on the pcb00 unit and on the lens.The customer's reported complaint could not be 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 and the reported issue could not be 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6404640
• MDR Text Key: 69945963
• Report Number: 2648035-2017-00481
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558052
• UDI-Public: (01)05050474558052(17)190910
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/10/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR