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

Model Number 1MTEC30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); No Code Available (3191)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided.The cartridge is not an implantable device.Medical devices: zcb00 intraocular lens, serial number (b)(4), dk7796 handpiece, serial# unknown/not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zcb00 19.5 diopter intraocular lens (iol) was implanted using a 1mtec30 cartridge in the right eye (od) on (b)(6) 2017.Post-op day one, the doctor diagnosed the patient as having no hyp-fibrin membrane-snowstorm and probable toxic anterior syndrome (tass).The doctor also found that the patient had significant endothelial folds-edema and fibrin.Therefore, the patient received topical antibiotics, intense steroids, and omidria.The patient was referred to a retina specialist.The iol remains implanted, there is no plan to explant.No additional information was provided.This report is for the cartridge.A separate report is being submitted for the zcb00 intraocular lens.

Manufacturer Narrative

Device evaluation: the product , cartridge was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Labeling review: the directions for use (dfu) was reviewed.The 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: 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: 6986003
• MDR Text Key: 90508396
• Report Number: 2648035-2017-01976
• 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: US
• PMA/PMN Number: K081382
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/06/2017
• 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
• Patient Outcome(s): Required Intervention