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

Model Number 1MTEC30

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Implant and explant dates: if implanted or explanted, give date: not applicable as this is not an implantable device all pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) got stuck in the cartridge during implantation.Only the cartridge tip touched the patient's eye.No incision enlargement, no vitrectomy was performed, no sutures were used and no patient post-op injury was reported.A back-up lens was used and the surgery went well.Reportedly, the cartridge was inspected and it seemed deformed on the tip.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 08/31/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed lack of lubricant material on the cartridge.Heavy dent/distortions and a crack were observed at the cartridge tip.The conditions of the product returned was consistent with a unit that was previously handled and prepared for surgical use.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators inspect the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.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: 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6816031
• MDR Text Key: 83537225
• Report Number: 2648035-2017-01544
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180103(10)CC00011
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/03/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC00011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• 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
• Treatment: ZXR00 LENS, SERIAL NUMBER (B)(4)