MAUDE Adverse Event Report: EUCLID SYSTEMS CORPORATION EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Model Number EMERALD

Device Problems Break (1069); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Doctor reported patient' corneal health was fine.No additional issues reported in the patient's medical condition till date.The subject device was returned and inspected.Inspection findings indicate that the surface, edge profile, power, center thickness and base curve values are within tolerance.Review of the device history record indicates that the lens was manufactured to specifications.

Event Description

On (b)(6) 2019, euclid systems corporation was notified of right side lens breakage within patient's eye.The lens was removed and no lasting consequences reported.

• Brand Name: EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
• Type of Device: EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
• Manufacturer (Section D): EUCLID SYSTEMS CORPORATION; 2776 towerview rd; herndon VA 20171
• Manufacturer (Section G): EUCLID SYSTEMS CORPORATION; 2776 towerview rd; herndon VA 20171
• Manufacturer Contact: sandra gilbert ; 45472 holiday drive; suite 7; sterling, VA 20166 ; 7034717145
• MDR Report Key: 9099317
• MDR Text Key: 195580066
• Report Number: 3002652243-2019-00002
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: EMERALD
• Device Lot Number: 18158PTC006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR