MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided.The product is not an implantable device.(b)(6).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after an implantation of a zxt tecnis symfony toric intraocular lens (iol), the doctor saw a glistening particle behind the lens, which he thinks is a piece of coating from the 1mtec30 cartridge used with the iol.Reportedly, the doctor was able to remove the glistening particle through irrigation and aspiration.There was no patient injury.No additional information was provided.

Manufacturer Narrative

The cartridge was discarded by the customer.The reported complaint was not verified.The manufacturing record evaluation and complaint history review could not be performed since the lot number is unknown.The directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.As a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• 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: 6970699
• MDR Text Key: 90763997
• Report Number: 2648035-2017-01928
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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