MAUDE Adverse Event Report: REVISION OPTICS/ RVO 2.0, INC RAIN DROP CORNEAL INLAY; IMPLANT, CORNEAL, REFRACTIVE

Device Problem Nonstandard Device (1420)

Patient Problems Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Inflammation (1932); Irritation (1941); Blurred Vision (2137); Visual Impairment (2138)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Had rain drop corneal inlay implanted in left eye approximately 2015-16.Developed vision problems and when i went in for a yearly eye check (032119) was informed of a recall of the lens and sent immediately to have it removed.The lens was removed on (b)(6) 2019 after i made an appointment.Did not receive information of the recall or any possible corneal haze, inflammation which could have lead to infection, issues i had been experiencing over the past year.I am experiencing post op dry eye along with irritation since the removal and being treated with steroids and antibiotics.Left eye blurry.Fda safety report id #: (b)(4).

• Brand Name: RAIN DROP CORNEAL INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): REVISION OPTICS/ RVO 2.0, INC
• MDR Report Key: 8482809
• MDR Text Key: 141023785
• Report Number: MW5085570
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 78