Exact FDA event identifier

Event 89463

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 17, 2022
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Lacrimedics Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Recall number: Z-0708-2022
Initiated: January 17, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Lacrimedics Inc
Quantity: 5767 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

device · product 2 of 2

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

Z-0709-2022

Recall number: Z-0709-2022
Initiated: January 17, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Lacrimedics Inc
Quantity: 4780 units