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 Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The cartridge is not an implantable device; therefore, not explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

The intraocular lens (iol) was loaded normally with no issues.When it was handed to the surgeon, he was unable to advance the iol.It was very tight.When the iol was pushed through, the inserter plunger left a mark on the iol.The surgeon also noticed debris was coming off the end of the cartridge when inserting the lens into the eye.A follow-up was made to clarify if the debris was inserted into the eye along with the iol.It was confirmed that the debris went into the patient¿s eye as the iol went into the eye.The surgeon did not explant the lens but instead aspirated out the debris.There was no patient injury and no vitrectomy.The incision had to be made larger than 2.4 millimeters.The procedure was completed successfully.The events occurred over 2 unknown surgery dates for a total of 8 cartridges.No additional information was provided to abbott medical optics.This report captures the event for cartridge 7 of 8.

Manufacturer Narrative

Correction: in the initial mdr, it was inadvertently reported that the product had been returned.Further review noted the product had not been returned.The following sections have been corrected: device available for evaluation: no.Device returned to manufacturer: no.Device evaluation: the product was not returned for evaluation.Therefore, the customer's reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu instructs the customer in the proper use of the device.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
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6330711
• MDR Text Key: 67437600
• Report Number: 2648035-2017-00295
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190912(10)CB39357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/12/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CB39357
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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