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

Model Number ZA9003

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Implant and explant date: if implanted or explanted; give date: na (not applicable) the lens was removed and replaced within the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that following implant of the intraocular lens (iol) small debris and/or particles were noticed on the lens.The particles/debris could have been lubricant from the cartridge.The lens was removed and an incision enlargement was required.A new lens was placed in the eye with out any complications.No further information was provided.

Manufacturer Narrative

Device available for evaluation ¿ yes, returned to manufacturer on 5/02/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.The lens was received cut in two pieces stuck together.Residues of what appear viscoelatic, particles and blood were observed.This condition is typically of an explanted or removed lens.Since the condition of the lens received the complaint cannot be verified since the complaint debris cannot be identified in the sample received.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaint have been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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: 6437950
• MDR Text Key: 70969177
• Report Number: 2648035-2017-00573
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)210923
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/23/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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