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 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

This is not an implantable device.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.The surgeon did not notice any abnormalities while loading the lens.The foreign material was removed during the irrigation/aspiration (i/a) procedure.The patient was not affected and the surgery was successful.The iol remains implanted.No further information was provided.

Manufacturer Narrative

Additional information was received and it was learnt that the intraocular lens (iol) remains implanted into the right eye of the (b)(6) female patient.Reportedly, there was no issue with the hand-piece and the intraocular lens (iol) was prepared as per dfu (directions for use).The amo viscoelastic healon was used during the lens implantation.No incision enlargement, no vitrectomy was performed, no sutures used and no serious patient injury was reported.The patient was reported doing fine.One day post-op: 20/25.The 3-week post-op: 20/20 uncorrected.(b)(6).And sex/gender: female.Concomitant medical products: healon, model and lot unknown.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 08/17/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residue of lubricant material on the cartridge.Slight dent/distortion at the cartridge tip were also observed.A chipped spot was noticed inside the cartridge.The spot was consistent with the physician¿s observation of sliver during the surgery.It was believed that the sliver was the coating material from the chipped spot inside the cartridge.However, the sliver was not available for analysis to confirm it; the sliver was not returned for analysis.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operator inspect the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.In addition sterilization records were reviewed: sterilization was processed and no deviations were found that affects the sterility of the device.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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: 6776189
• MDR Text Key: 82126181
• Report Number: 2648035-2017-01453
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180213(10)CC01834
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC01834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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
• Treatment: LENS ZCB00, SERIAL NUMBER (B)(4)
• Patient Age: 71 YR