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

Model Number PCB00

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown, not provided.Sex/gender: unknown, not provided.Date of event: unknown, not provided.If implanted; give date: unknown, not provided.If explanted; give date: unknown, not provided.(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and 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.

Event Description

It was reported that a broken haptic was noticed on an intraocular lens (iol), after implantation.The lens had to be explanted (in a secondary procedure) and replaced with another lens.Reportedly, the surgical procedure was not easy.No further information was provided.

Manufacturer Narrative

Device available for evaluation: yes.Device returned to manufacturer on: 06/21/2017.Device returned to manufacturer: yes.Device evaluation: the intraocular lens was returned to the manufacturing site for investigation.The complaint unit was received in the original folding carton.The plunger was observed in a fully advanced position and the cartridge was correctly engaged into lower body of the pcb00 delivery device.No assembly error and/or defect related to manufacturing process was observed.Visual inspection at 10x microscope magnification was performed.Viscoelastic residue was not observed in the returned product.The lens was received out of the delivery device and was cut in two pieces, and is related to the lens explant,.The lens was found with a detached haptic.The detached haptic was not received.The reported issue was verified.However, the condition in which the lens sample was received indicates that the sample was handled and prepared for the surgical process.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: 6297834
• MDR Text Key: 66393172
• Report Number: 2648035-2017-00209
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558250
• UDI-Public: (01)05050474558250(17)191126
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

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: 11/26/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2016
• 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 Outcome(s): Required Intervention