MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number ZMB00

Device Problems Difficult or Delayed Positioning (1157); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during insertion of a zmb00 intraocular lens (iol), the lens got stuck in the cartridge.The lens was partially inserted.Reportedly, a non-amo cartridge was used to deliver the lens.There was a slight incision enlargement which did not require sutures.There was no vitrectomy required.The patient was reported as well post op.No other patient injury occurred.No further information was provided.

Manufacturer Narrative

The intraocular lens (iol) was returned to the manufacturer in the original folding carton.Visual inspection at 10x microscope magnification showed loose particles on the iol consistent with handling of the lens out of the sterile environment.Both haptics were observed in good condition and shape.The customer's reported complaint could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5617756
• MDR Text Key: 43979425
• Report Number: 9614546-2016-00197
• Device Sequence Number: 1
• Product Code: MFK
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/05/2019
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• 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