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 Pain (1994)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

The subject device has been returned for inspection.A comprehensive conclusion of the investigation findings will be provided in the supplemental or follow-up report.

Event Description

On august 12, 2019, euclid systems corporation was notified of left side lens breakage within patient's eye.The lens was removed and no lasting consequences reported.(reference mw5088662).

Manufacturer Narrative

No additional issues reported in the patient's medical condition till date.Patient was refit in soft lens product.The subject device was returned and inspected.Inspection findings indicate that the edge profile, power, center thickness and base curve values are within tolerance.Lens surface shows signs of usage.Review of the device history record indicates that the lens was manufactured to specifications.

Event Description

On august 12, 2019, euclid systems corporation was notified of left side lens breakage within patient's eye.The lens was removed and no lasting consequences reported.(reference mw5088662).

• 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
• MDR Report Key: 8899325
• MDR Text Key: 154556578
• Report Number: 3002652243-2019-00001
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• PMA/PMN Number: P040029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/28/2023
• Device Model Number: EMERALD
• Device Lot Number: 18186PTC002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMERALD (GREEN) (B)(6) ; EMERALD (GREEN) (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR