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

Model Number 1MTEC30

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown/not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Phone: unknown/ not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the cartridge tip was bent when the user opened the carton and that the intraocular lens (iol) got stuck inside the cartridge no additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 8/28/2017.Device returned to manufacturer? yes.Device evaluation: the returned 1mtec30 cartridge was received inside a pouch in a bag with a zxr00 lens case.The cartridge was observed under microscope 10x magnification and residues of what appears to be viscoelastic were observed only in the cartridge tube.Viscoelastic residues were not observed in the loading zone of the cartridge.The cartridge tube was observed broken by one side.A lens was observed stuck in the cartridge tip with part of the haptic out.The complaint was verified however the cartridge breakage could appear to be caused with the pushrod handpiece due to the scarce amount of viscoelastic observed.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 provide the customer with proper usage instructions and guidelines.Conclusion: 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: 6860688
• MDR Text Key: 86148709
• Report Number: 2648035-2017-01642
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 15050474540320
• UDI-Public: (01)15050474540320(17)180519(10)CC05983
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 10/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/19/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC05983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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