Z-0708-2022Class II

OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye...

Name: Z-0708-2022 OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye...
Creator: Lacrimedics Inc
Published: 2022-01-17
License: https://open.fda.gov/license/

Lacrimedics, Inc. / initiated 2022-01-17 / Open, Classified / root cause: packaging

FDA source

Lacrimedics Inc began a recall of OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment on 2022-01-17. FDA classified it as Class II and gives the reason as "The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0708-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-17
Posted: 2022-03-01
Recalling firm: Lacrimedics, Inc.
Product: OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Product code: LZU Plug, Punctum
Reason for recall: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs customer letters, dated January 17, 2022 and Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs distributor letters, dated January 17, 2022 sent starting 1/24/2022 (through 1/28/2022 US and 2/4/2022 (OUS)) via USPS certified letter with return receipt; Distributors and customers are instructed in letter to discontinue distribution and/or use and return remaining product for replacement " Contact their customers regarding the product(s) and request the return of remaining product for replacement. (distributors) " Acknowledge recall by returning the Recall Response Form to Tanya Traband: [email protected] or FAX: (253) 964-2699 or Lacrimedics, Inc. 2620 Williamson Place, Suite 113 DuPont, WA 98327 Other information: Contact Tanya Traband, Manager Client Relationships, at [email protected] or +1.800.367.8327 Ex. 200 Monday through Friday 8:30 a.m. to 4:00 p.m. PST. " Direct customers are instructed to return product for replacement; prepaid UPS labels are sent with the letter for this purpose
Quantity in commerce: 5767 units
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0709-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code LZU

K021831UnclassifiedOpaque Herrick Lacrimal Plug, 0.3Mm,0.5mm,0.7mm, Models Hlp3-Opb,hlp50opb,hlp7-OpbLacrimedics, Inc. / cleared 2002-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)