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

Model Number 1MTEC30

Device Problems Material Fragmentation (1261); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Concomitant medical products - tecnis symfony zxr00, serial number (b)(4).Phone number: (b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during implantation of an intraocular lens (iol) a small piece of plastic from the cartridge 1mtec30 was delivered into the patient's eye together with the lens.Loading was done by experienced nurse with no reportable issues.The surgeon felt slight resistance during implantation.During removal of the ovd (ophthalmic viscosurgical) the piece of plastic was noticed inside the eye; it was successfully removed and it was discharged.Afterwards the cartridge tip was reported looking "strange".The iol itself was okay.There will not be additional follow ups with the patient due to this event but only normal post-operation check-ups.The sales rep noted that the cartridge looked like there is rupture in "lower lip" of the tip; some sort of torn flap.

Manufacturer Narrative

Device evaluation: the cartridge was returned at the manufacturing site for investigation.Visual inspection at 10x microscope magnification showed viscoelastic residue inside the cartridge tube/tip.No debris/particles were observed in the cartridge.The cartridge tip was observed cracked.The condition of the unit is consistent with a cartridge that has been damaged by the metal rod tip of the hand piece.The rod tip protruded through to the cartridge tip creating the cracked cartridge.The customer's reported complaint was verified.Manufacturing records review: the manufacturing process record was evaluated.There were no non conformances, discrepancies or deviations for similar issues that were found during the manufacturing record review.During the manufacturing process the operators check the neck, tube, and tip areas of the cartridge for cracks, melting, roughness, dent, bent tips or smash conditions.No cracking or stress marks are allowed.A search on complaints revealed that no other complaints were opened under this lot number and production order.The manufacturing record review and related documents revealed that the cartridge was manufactured and released according to specification.Labeling review: the directions for use (dfu) for the cartridge was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the cartridges.As a result of the investigation there is no indication of a product quality deficiency and the 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
• 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: 5620717
• MDR Text Key: 44078416
• Report Number: 2648035-2016-00673
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/23/2016
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CA16085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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