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 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Only a partial udi number is known, as the lot number was not provided.The product is not an implantable device.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a 1mtec30 cartridge was used with a zxr00 19.0 diopter intraocular lens (iol) for cataract surgery of the right eye (od) on (b)(6) 2017.Post-operatively, at a follow up visit with the surgeon on (b)(6) 2017, the patient's right eye was tested with the following results: uncorrected visual acuity was 20/25-2, manifest distance visual acuity 20/25+1, and manifest near va j1+.During the next follow up visit on (b)(6) 2017 the uncorrected visual acuity in the right eye was still 20/25, but the doctor reported a translucent foreign body that was perfectly round and spherical in the posterior segment that resembles a piece of plastic.Reportedly, the foreign body was not affecting the patient's vision and the patient did not want to have a vitrectomy to remove the foreign object.Furthermore, the doctor suspected the foreign material could have come from the lens or cartridge.A referral to a retinal specialist was then recommended.The patient was referred to a second doctor, a retinal specialist, and was seen on (b)(6) 2017.The patient stated about a month ago that a large black spot (round) was seen in their right eye at the top of their vision on occasion that would float down into their center vision.The patient denied flashes and pain.The doctor reported there was no associated inflammation.No additional information was provided.The patient had bilateral lenses implanted.This report captures the cartridge used with the lens implanted in the patient's right eye.

Manufacturer Narrative

The product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record evaluation could not be performed since lot number is unknown.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.

Manufacturer Narrative

Corrected data: in mdr follow up #1, under 2648035-2017-01839, an incorrect date was entered in date received by mfr.The correct date should have been entered as 10/27/2017; however, was entered as 10/24/2017.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: 6932466
• MDR Text Key: 89957878
• Report Number: 2648035-2017-01839
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• 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,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 67 YR