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

Model Number PCB00

Device Problem Premature Activation (1484)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer indicated that the date of event occurred from (b)(6) 2015 to (b)(6) 2015.Implant date: unknown.Explant date: not applicable; lens remains implanted at the time of submitting the mdr.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the customer experienced some issues with different pcb00 in different dates from (b)(6) 2015 to (b)(6) 2015.The distal loop was opened in an advanced position at the moment of the insertion and slightly out of its cartridge, for this reason the surgeon is constrained to more complicated proceedings like re-loading the lens in another inserter.All lenses have been implanted, but the surgeon was not happy to losing time about 4/5 minute delay in the procedure.There was no patient injury reported and no secondary surgery or medical intervention required.No further information was provided.Note: the customer experienced issues with two preloaded insertion systems.Both medwatch reports will be filed separately for each serial number.This report is for serial number (b)(4).

Manufacturer Narrative

No product was returned for evaluation.Therefore, a visual inspection could not be performed and 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.

Manufacturer Narrative

On december 1, 2015, two (2) patients¿ gender and dates of birth were provided by the customer but it is unknown which date of birth and gender applies to this report.(b)(6).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: 5069290
• MDR Text Key: 25495863
• Report Number: 2648035-2015-00782
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup
• Report Date: 12/22/2015

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: 04/28/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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