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

Model Number 1MTEC30

Device Problems Crack (1135); Difficult to Insert (1316); Device Slipped (1584); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that lens was loaded in the cartridge and when the doctor was inserting the product into the patient's eye and trying to advance the cartridge cracked and the plunger went right thru.They reported that the tip of the cartridge touched the eye.No patient injury.Surgeon changed to a back-up lens and everything went well.

Manufacturer Narrative

The cartridge and the intraocular lens were returned to the manufacturer for evaluation.Visual inspection of the return sample revealed that the lens was not returned in its original package.The return cartridge was visually inspected under a microscope.A crack was observed at the cartridge tip and residues of viscoelastic solution were observed on the cartridge tip, the tube and the loading zone areas.Surface residuals (fiber/particles) were also observed.The cause of the crack could be related to the handling of the lens during the insertion process.A review of the directions for use (dfu) was conducted.The dfu adequately provides instructions and warnings for proper use and handling of the device.The manufacturing record review was performed.The lens was manufactured within specifications.There is no associated deviation or non-conformity report found in the manufacturing record review (mrr).The device manufacturing procedures were performed as required.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: 5125646
• MDR Text Key: 27610938
• Report Number: 2648035-2015-00885
• Device Sequence Number: 1
• Product Code: KYB
• 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: Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CA08172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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