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

Model Number ZA9003

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If implanted; give date: not applicable.Event occurred during insertion of the iol.If explanted; give date: not applicable.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during insertion of a za9003 intraocular lens (iol) into patient's left eye, bent haptic was noted and as the doctor was pulling lens out, the haptic broke.Initially it was reported that there was no incision enlargement.Additional information was received stating that an incision enlargement was required.There was no other patient injury reported.The iol was removed and replaced with an anterior chamber lens with no other complications.No further information was provided.

Manufacturer Narrative

The lens was returned to the manufacturer for evaluation.Visual inspection at 10x microscope magnification showed the lens was returned with one lens haptic distorted/bent, and detached confirming the codes reported.There is no issue with the other haptic.Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device) was detected in the lens optic body.The reported ''haptic damaged'' and ¿haptic detached¿ were verified.Manufacturing records were reviewed and the lens was manufactured according to specification.No non-conformance reports (ncrs), deviations, or discrepancies were issued during the manufacturing process.A search on complaints revealed no this is the only investigation request issued for this order number to date.The directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the historical complaint review, analysis of the return, manufacturing record review, and labeling 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
• 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: 5749472
• MDR Text Key: 48189186
• Report Number: 2648035-2016-00990
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2016
• 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
• Patient Outcome(s): Required Intervention