ISee Ortho-K Lens

FDA device recall Z-2515-2023 · posted 2023-09-05 · Open, Classified

Recall details

Recalling firm

PARAGON VISION SCIENCES, Inc

Reason for recall

Manufactured lenses are not covered by existing FDA approval

Action taken

On June 26, 2023, CooperVision on behalf of Paragon Vision Sciences issued an email communication indicating they had suspended U.S. Distribution. On July 26, 2023, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees via: letter or E-Mail. CooperVision asked consignees to take the following actions: 1. Existing patients should be transitioned from the iSee/Fargo product to an alternate treatment as soon as possible. 2. Identify appropriate alternate options for the patients. Potential alternative options include the, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees. following: " Different lenses, including those available from other manufacturers that you determine to be appropriate based on your assessment of patient suitability and treatment type. " Glasses that can provide the appropriate reduction in myopic refractive error for the patient, based on your assessment of patient suitability and treatment type. 3. During this transition time, current patients can continue to wear their lenses to continue their treatment. This includes continued access to replacement lenses as deemed necessary by you, the ECP, until the patient can be adequately refit and transitioned to a different product to continue their treatment. NOTE: This only applies to patients currently undergoing treatment with these lenses. No new patients will be provided access to these lenses. 4. Sign and return a copy of the attached Medical Device Correction Response Form acknowledging your receipt and understanding of the provided information. 5. Provide a copy of this letter to your patients. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax

Root cause

Process control

Status

Open, Classified

Product code

NUU

Quantity affected

83,542 lenses

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, N

Date initiated

2023-06-26

Date posted

2023-09-05

Location

Gilbert, AZ