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

Model Number ZA9003

Device Problems Material Distortion (2977); Appropriate Term/Code Not Available (3191); Device Handling Problem (3265)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an explant of an intraocular lens, model za9003, was performed.However, it was also reported that there was no patient contact.Through follow-up with the surgery center, the reported explant was not confirmed.The site indicated a possible mechanical implantation issue.No further information was provided.

Manufacturer Narrative

Additional information was received in a follow-up that also corrects some information in the initial mdr.Additional information: the event date was (b)(6) 2015.It was reported that the lens never touched the patient.The scrub technician had issues folding the lens.When the lens was passed through cartridge at sterile field and handed over to the surgeon, it was noticed that it did not look ok.The haptic was bent out of shape.It was an issue with insertion into the cartridge; it was reported as a user error.Dr.(b)(6) was the name of the surgeon from the same facility reported in the initial mdr.(b)(4).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: 5400000
• MDR Text Key: 37179491
• Report Number: 2648035-2016-00143
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/18/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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