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Recall Observatory FDA recall evidence

Device product

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

Z-0708-2022

January 17, 2022

Class II

Product summary

Firm
Lacrimedics Inc
Event
Event 89463
Status
Ongoing
Classification
Class II
Quantity
5767 units
Official record key
device-enforcement:Z-0708-2022

Official wording

Reason: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch seal may contain channels that could affect the seal integrity and potentially compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise