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 Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

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 doctor had approximately 8 cases with the platinum cartridge where he noted a transparent "filament" type of substance coming out of the cartridge that was attaching itself to the trailing haptic during the implantation/delivery process.Once they changed cartridge lot number, without making changes to the surgical technique, this did not occur with the rest of the cases.The substance that came out of the cartridge with the intraocular lens was very fine, clear, wrinkled membrane-like (similar to capsule or descemet's).The doctor was able to use irrigation/aspiration to remove the substance out of the eye in each case.No additional information was provided to abbott medical optics.Note: 8 mdr¿s are being submitted for the 8 reported cases.This is mdr 4 out of 8.

Manufacturer Narrative

Device evaluation: the product was not returned for investigation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.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: 6847375
• MDR Text Key: 85143660
• Report Number: 2648035-2017-01607
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180630(10)CC08053
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC08053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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