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

Model Number PCB00

Device Problems Bent (1059); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after an intraocular lens was implanted in the right eye of a male patient using the preloaded insertion system, model pcb00, the surgeon noticed that the haptic was bent.Next day post-op, the surgeon noticed that the lens seemed to be decentered.The patient was brought back to surgery a month later to explant the lens and replace with a model z9002.There was no incision enlargement, no sutures, and no patient injury.No additional information was provided.

Manufacturer Narrative

(b)(6).Device evaluation: the explanted intraocular lens was returned to the manufacturing site for investigation.Visual inspection at 10x microscope magnification was performed.The lens was observed cut in two parts.One lens haptic was observed detached.The detached portion of the haptic was not returned.The other haptic was observed bent.The condition observed in the lens and the way in which the cut is formed is consistent with a lens that has been cut due to an explant.The reported complaint issue was verified.Manufacturing record review: a review of the manufacturing records was performed.The manufacturing production order was evaluated and the devices were manufactured within specifications.The units were released according to specification.The review did not identify any non-conformance reports (ncr) there were related to the customer's reported complaint.Labeling review: the directions for use (dfu) was reviewed and adequately provides instructions, precautions, and warnings for the proper use and handling of the intraocular lenses.Based on the manufacturing records review, analysis of the returned lens, historical complaint review and non-conformance/capa review, there is no indication of a product malfunction or product quality deficiency.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 ; 1742478243
• MDR Report Key: 5716245
• MDR Text Key: 47091126
• Report Number: 2648035-2016-00896
• Device Sequence Number: 1
• Product Code: HQL
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/27/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR