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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

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.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the intraocular lens (iol) was stuck in an (b)(4) cartridge.It was later clarified by the customer that there was no iol involved.The issue was that there was an extra bit of plastic at the tip of the cartridge.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation, returned to manufacturer on 12/28/2017.Device evaluation: the cartridge was received inside the cartridge tray.The cartridge was observed under 10x microscope magnification and the cartridge was observed broken in the tip with a torn part.Scarce amount of viscoelatic residues was observed in the inside pf the cartridge.The condition of the cartridge tip appears to be caused by the force of the hand piece push rod since a scarce amount of viscoelastic was used.The complaint was verified however due the condition of the cartridge the complaint cannot be related to manufacturing process; it could be related to the handling process.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.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: 7103015
• MDR Text Key: 95066199
• Report Number: 2648035-2017-02249
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180505(10)CC05620
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

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: 05/05/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC05620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/10/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2017
• 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