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Class 2 Device Recall Healon GV PRO |
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Date Initiated by Firm |
December 03, 2019 |
Date Posted |
January 27, 2020 |
Recall Status1 |
Terminated 3 on April 28, 2021 |
Recall Number |
Z-0867-2020 |
Recall Event ID |
84411 |
PMA Number |
P810031 |
Product Classification |
Aid, surgical, viscoelastic - Product Code LZP
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Product |
Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14 |
Code Information |
Model: 10-2400-14, Lots: UE31164, UE31214, UE31440, UE31478, UE31521, UE31560. Model: 10-2705-14, Lots: UE31098, UE31204, UE31283, UE31306, UE31364, UE31409, UE31467, UE31476, UE31507, UE31519, UE31588, UE31408, UE31439, UE31559, UE31587. |
Recalling Firm/ Manufacturer |
Johnson & Johnson Surgical Vision Inc 1700 E Saint Andrew Pl Santa Ana CA 92705-4933
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Manufacturer Reason for Recall |
Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.
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FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Customers were asked to immediately take the following actions:
1. Compare your inventory against the affected product list.
2. Discontinue using and remove from your inventory all affected lots.
3. Even if you have no inventory, please complete the Customer Reply Form.
If you have inventory of any of the affected OVDs products, please complete the Customer Reply
Form, noting the lot numbers of the OVDs, and use the shipping label provided to return the product. Returned product will NOT require refrigerated shipping. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. Customers may call 1-877-266-4543 Option 2 if they have additional questions or want to report complaints or adverse events. |
Distribution |
U.S.: CA, PA, NJ, GA, IL, MO, CO, TX, FL, AK, NY, HI, UT, LA, OH, IN, MA, NC, AZ, MI, NH, AL, TN, WA, MD, OR, VA, MS, MN, KY, AR, NV, WI, WV, SC, DE, ME, CT, ID, NM, VT, IA, OK, MT, NE, DC.
OUS: DE, GB, DK, IT, NL, TR, AT, CH, FR, GR, ES, PT, FO, BE, GP, ZA, IE, HR, HU, IS, NO, SE, FI |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LZP and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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