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U.S. Department of Health and Human Services

Class 1 Device Recall Raindrop Near Vision Inlay

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  Class 1 Device Recall Raindrop Near Vision Inlay see related information
Date Initiated by Firm November 13, 2018
Date Posted March 05, 2019
Recall Status1 Terminated 3 on March 14, 2024
Recall Number Z-0865-2019
Recall Event ID 81812
PMA Number P150034 
Product Classification Implant, corneal, refractive - Product Code LQE
Product Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Code Information All lots of unused product
Recalling Firm/
Manufacturer		 RVO 2.0, INC
26800 Aliso Viejo Pkwy
Ste 160
Aliso Viejo CA 92656-2625
For Additional Information Contact
720-350-8850
Manufacturer Reason
for Recall		 During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 11/13/2018, the firm started emailing Urgent Medical Device Recall notices and acknowledgment forms to consignees. This recall notice was intended for 1) patients implanted with the Raindrop Inlay and 2) eye care providers. Eye care providers were asked to cease further implantation and to return unused affected devices to the recalling firm. Eye care providers were informed that patients implanted with affected devices should continue to see their eye care providers on a regular basis, preferably every 6-months and no less often than every 12 months. Also, patients who have had their devices explanted should maintain a follow-up schedule with their provider. The firm commits to physicians to support the patient's best interests and to continue the FDA post approval study to monitor the device's ongoing performance and safety. The firm requests that all consignees complete and return, acknowledgement forms, regardless of whether they do or do not have unused affected product to return. Acknowledgement forms should be returned via email to Jennifer.Luong@opticsmedical.com. Customers with questions are encouraged to call 949-330-6511.
Quantity in Commerce 2869
Distribution U.S.: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA; No OUS (Foreign) Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LQE and Original Applicant = RVO 2.0, Inc. (d.b.a. Optics Medical)
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