MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

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

Event Date 08/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Implant date: not applicable; the lens was not implanted in the patient¿s eye.Explant date: not applicable; the lens was not implanted in the patient¿s eye.Concomitant medical devices: emeraldc30 cartridge, lot #: unknown.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that while inserting, the surgeon had a problem inserting the lens into the patient's right eye.The lens was not implanted.Reportedly, the patient has recovered.No further information was provided.

Manufacturer Narrative

Additional information provided by the customer confirmed that there was no patient injury post-operative.However, the customer could not remember how the event occurred.The customer could not confirm if the lens was removed or replaced during the same procedure and if there was incision enlargement or vitrectomy performed.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

The intraocular lens was returned to the manufacturer for evaluation and inspected at 10x microscope magnification.The lens was observed with viscoelastic residues, fibers and particles.The haptics were observed bent.As reported, the surgeon had problem inserting the lens, the condition of the return is consistent with the product preparation and use.Manufacturing records were reviewed and the lens was manufactured according to specification.No issues were reported during the manufacturing process of this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Manufacturing issues and/or indication of a product quality deficiency was not identified based on the analysis of the return, manufacturing record review and evaluation performed.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• 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: 5208734
• MDR Text Key: 30687201
• Report Number: 2648035-2015-01122
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• 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,Followup
• Report Date: 03/07/2016

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: 05/28/2018
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/06/2015; 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2013
• 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: 50 YR