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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97463

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

Open FDA event record

Event summary

Timeline bucket
August 18, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CORNEAT VISION, LTD.

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

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Z-0039-2026
Recall number
Z-0039-2026
Initiated
August 18, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CORNEAT VISION, LTD.
Quantity
630 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Code information

All Lots/ UDI: G16010362950

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.

device · product 2 of 2

EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202

Z-0040-2026
Recall number
Z-0040-2026
Initiated
August 18, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CORNEAT VISION, LTD.
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Code information

All Lots/ UDI: G16010440020

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.