MAUDE Adverse Event Report: GLAUKOS CORPORATION IPRISM CLIP; RING, OPHTHALMIC (FLIERINGA)

Model Number IPC05

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.The investigation is in progress and findings will be provided in a supplemental report.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.As part of the device history records review, the sterilization records for this lot were reviewed and this device lot passed sterility tests.A complaint history review was completed for this lot # and no similar issues have been reported.(b)(4).

Event Description

The customer reported that prior to patient contact, a foreign material was observed in the packaging of an unopened iprism clip.There was no patient contact as the product was not used.A back up product was opened and used for the case.

Manufacturer Narrative

The device was returned to the manufacturer, and it was found sealed in the original packaging.Visual inspection of the returned device confirmed the reported issue.A review of past complaints was conducted, and there was no increase in frequency for the reported complaint issue.Mfr# reference: (b)(4).

• Brand Name: IPRISM CLIP
• Type of Device: RING, OPHTHALMIC (FLIERINGA)
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 7533637
• MDR Text Key: 109010502
• Report Number: 2032546-2018-00047
• Device Sequence Number: 1
• Product Code: HNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2018
• Device Model Number: IPC05
• Device Lot Number: 9441442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1