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

Model Number 1MTEC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that doctor observed plastic residue on the back of the monofocal intraocular lens (iol) which doctor could not polish off.Doctor later changed to a cartridge of a different lot number.Additional information was received and it was learnt that doctor believes the particles were coming from cartridge.The lens was removed and replaced.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

Additional information: device available for evaluation, returned to manufacturer on 12/11/2017.Device evaluation: the 1mtec30 cartridge was returned to the manufacturing site for evaluation.Visual inspection was performed using microscope magnification which showed no defects on the returned cartridge such as missing part, broken or cracks that could lead to the reported issue.Only residues of dry viscoelastic at the cartridge tip, tube, and loading zone were observed.No plastic particles at any section of the cartridge were detected during sample evaluation.The reported plastic particle observed by the surgeon was not returned for investigation.The condition observed in the returned cartridge is consistent with unit that has been handled and prepared for surgical use.The customer's reported complaint was not verified.The sample was sent for fourier transfer infrared (ftir) analysis.Ftir spectra analysis indicates the presence of sodium hyaluronate on the interior surface of the cartridge unit in question.Per the instruction for use (dfu) sodium hyaluronate is related to viscoelastics (ophthalmic viscosurgical devices (ovds).And the ovds products is consistent with sodium hyaluronate.Therefore, there is no evidence to suggest that the reported 1mtec30 cartridge was affected by the manufacturing process.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be 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: 7115064
• MDR Text Key: 95066510
• Report Number: 2648035-2017-02262
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180830(10)CC10774
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC10774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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