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 Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If explanted, give date: not applicable, cartridge is not an implantable device.If explanted, give date: not applicable, cartridge is not an implantable device.Initial reporter phone number: unknown, information not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the intraocular lens (iol) was stuck inside a 1mtec30 cartridge and the cartridge tip was bent.No additional information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 08/06/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that an intraocular lens (iol) was stuck in the cartridge tube with a haptic out of the cartridge tip.A very scarce amount of viscoelastic residue was observed in the middle of the cartridge tube however no viscoelastic residue was observed in the loading zone of the cartridge.The cartridge tube was observed broken (no bent) with part of the lens out of the cartridge.The breakage appeared to be caused by the pushrod hand piece due to the scarce amount of viscoelastic observed.The customer's reported complaint for cartridge tip bent was not verified.Also fourteen (14) unused cartridges were returned as representative samples.Visual inspection at 10x microscope magnification showed that the cartridges were in good condition and no defects were detected.All cartridge tubes and tips were observed without damages.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators check 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.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to fill with viscoelastic the entire inside of the cartridge.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was not verified.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Corrected data: upon further investigation of the returned sample it was confirmed that the cartridge tip was observed bent.Therefore the customer's reported complaint was 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: 6829167
• MDR Text Key: 83944339
• Report Number: 2648035-2017-01567
• 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,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 10/04/2017
• Supplement Dates FDA Received: 09/28/2017; 10/27/2017
• 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