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 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

This is not an implantable device.Device manufacture date: unknown as the lot number was not provided.Note: two lot numbers were provided but it is unknown which one was used in 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 a sliver of material was present on the posterior surface of the intraocular lens (iol).The customer believes it may have come from inside the cartridge.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Additional information: during follow-up it was reported that a clear, film-like substance was noted on the back of the intraocular lens (iol) immediately after iol implantation in the right eye.The substance was removed with irrigation and aspiration with no other detrimental intra- or post-operative effects noted.The debris is not available for analysis.The cartridge is not available for analysis.The debris was located in the posterior aspect of the iol.The lens was prepared per the directions for use (dfu) the viscoelastic used during the surgery was amvisc plus.There was no visible damage in the cartridge after iol delivery.The lens remains implanted.No incision enlargement, no serious patient injury, no sutures, no vitrectomy.The patient outcome is good as no postoperative adverse event.(b)(6).Sex/gender: male.Lot#: cc04219.Expiration date: 4/7/2018.(b)(4).Concomitant medical products: zcb00, serial (b)(4).Device manufacture date: 4/7/2017.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) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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: 6812602
• MDR Text Key: 83531411
• Report Number: 2648035-2017-01533
• 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
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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: CC04219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• 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: 67 YR