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 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown/ not provided.Expiration date: unknown as the lot number was not provided.Unique identifier (udi#): complete udi is unknown as the lot number was not provided.This is not an implantable device.Two lot numbers were provided but it is unknown which one was used and refers to this event.Lot cc04219, (b)(4).Lot cc04220, (b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that after the insertion into the eye of an intraocular lens (iol) a sliver material was observed on the posterior side of the lens.Reportedly, the foreign material was believed to come from inside the cartridge.No further information was provided.

Manufacturer Narrative

(b)(6).Gender/sex: male.Lot number: cc04220.Expiration date: 04/07/2018.(b)(4).Concomitant medical products: zcb00 22.0 diopter intraocular lens sn (b)(4).Device manufacture date: 04/07/2017.Additional information received reported the patient is male with a (b)(6).Also, the intraocular lens was a zcb00 22.0 diopter intraocular lens (iol).The description of the silver material was further clarified as a clear, film-like substance and that it was removed through irrigation and aspiration with no other detrimental intra- or post-operative effects noted.The lot number for the cartridge was clarified as cc04220.The lens remains implanted.There was no incision enlargement, vitrectomy, sutures used, or patient injury.The patient's outcome is good and there are no post-operative adverse events.No additional information was provided.Device evaluation: 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 records review: the manufacturing records for the intraocular lens 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.

Manufacturer Narrative

A photo of the implant was received and it was evaluated.The presence of a particle was observed, however the source could not be determined.No material analysis could be performed because the particle was not returned.The customer's reported complaint for foreign material on the lens was verified but it could not be determined what it was specifically.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: 6812398
• MDR Text Key: 83296843
• Report Number: 2648035-2017-01527
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/07/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC04220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• 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
• Patient Age: 76 YR