OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Summary
The FDA issued a Class II for OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO by Lacrimedics Inc. Reason: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility..
Details
Source
Device Recall
External ID
Z-0708-2022
Action Date
2022-03-09
Status
Ongoing
Category
device
Product Description
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Lot/Code Info: HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Quantity Affected: 5767 units
Reason for Recall
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Distribution
Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-17
Company
Dupont, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Lacrimedics Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lacrimedics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lacrimedics Inc have FDA actions?
Lacrimedics Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0708-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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