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); Difficult to Insert (1316)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Explant date: not applicable; lens remains implanted at the time of submitting.(b)(6).All pertinent information available to abbott medical optics has been submitted.Placeholder.

Event Description

It was reported that during implantation of the intraocular lens, the trailing haptic was stuck between the cartridge tip and pushrod.The surgeon released the haptic by using forceps.The haptic was unbroken and the lens was centered normally.The surgeon noticed a small print in the intraocular lens possibly from the pushrod tip, but there was no need to be explanted or any other action or further action related to patient and no visual problems or any other adverse effect to the patient.No further information was provided.

Manufacturer Narrative

The pcb00 unit was returned to the manufacturer for evaluation.The device was visually inspected under the microscope at 10x magnification.Scarce ovd (ophthalmic viscoelastic) residues were observed inside the cartridge.The plunger was observed loaded as required and engaged.The cartridge was observed in the correct position (fully engaged into lower body of the pcb00 device).No damages were observed.The lens remains implanted; therefore, the claim reported could not be verified.Manufacturing records were reviewed and the pcb00 units were manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.He directions for use (dfu) was reviewed.The dfu and the precaution sections adequately provide instructions and precautions for the proper use and handling of the product.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: 5317030
• MDR Text Key: 34075174
• Report Number: 2648035-2015-01347
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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: Health Professional
• Device Expiration Date: 11/20/2017
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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