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

Model Number ZA9003

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Gender/sex: unknown, was not provided.If implanted; give date: na (not applicable) the lens was removed and replaced within the same surgery.If explanted; give date: na (not applicable) the lens was removed and replaced within the same surgery.(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for investigation.Inspection was performed at 10x microscope magnification.The lens was received cut in two parts.One lens haptic was observed detached.The detached haptic piece was not returned.The other lens haptic was observed distorted confirming the reported issue of a bent haptic.The lens condition observed is consistent with a unit that has been cut due to the iol removal process as reported.Loose particles were observed on the lens and compatible with handling of the lens.Viscoelastic residue was detected on the lens.The customer's reported event was verified on the returned lens sample.Manufacturing record review: a review of the manufacturing records was performed.There were no discrepancies found during the review.The documentation shows that the production order was manufactured according to specifications.There were no non-conformance reports that were related to the customer's complaint.The units were released according specification in compliance with the product intended use as required.A search on complaints revealed that no other complaints have been received for this production order number.Labeling evaluation: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the lenses.Based on the results of the investigation, no quality product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the intraocular lens (iol) was removed and replaced as the haptic was bent.The lens was replaced with the same model.An incision enlargement and suture were required.No further information was provided.

• 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: 6411011
• MDR Text Key: 70131015
• Report Number: 2648035-2017-00504
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529038
• UDI-Public: (01)05050474529038(17)210415
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2017

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: 04/15/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• 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
• Treatment: EMERALD CARTRIDGE, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR