Scleral Buckling Products: Style 41, 3.5mm Silicone Strip 92-09Recalls & reported problems

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717872014319), received between Mar 16, 2018 and Mar 16, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Patient-Device Incompatibility2

Patient problems

Reaction2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 16, 2018Patient-Device Incompatibility
IT WAS REPORTED A PATIENT HAD A SCLERAL BUCKLE IMPLANTED IN RIGHT EYE ONE YEAR AGO. THE PATIENT THEN HAD AN ALLERGICE REACTION ON THE SKIN SURROUNDING HER EYE AND WAS SEEN BY A DERMATOLOGIST.. THE PATIENT WAS EVALUATED FOR A POSSIBLE ALLERGIC REACTION RELATED TO SILICONE. IT WAS REPORTED THE MD WANTS TO PERFORM AN ALLERGY TEST.
Patient problems: Reaction
MAUDE report 7346904 ↗
InjuryMar 16, 2018Patient-Device Incompatibility
IT WAS REPORTED A PATIENT HAD A SCLERAL BUCKLE IMPLANTED IN RIGHT EYE ONE YEAR AGO. THE PATIENT REPORTEDLY HAD AN ALLERGIC REACTION ON THE SKIN SURROUNDING HER EYE AND WAS SEEN BY A DERMATOLOGIST. THE PATIENT WAS EVALUATED FOR A POSSIBLE ALLERGIC REACTION RELATED TO SILICONE. IT WAS REPORTED THE MD WANTS TO PERFORM AN ALLERGY TEST.
Patient problems: Reaction
MAUDE report 7346826 ↗

Device details

UDI-DI	`08717872014319`
Brand	Scleral Buckling Products: Style 41, 3.5mm Silicone Strip
Model	92-09
Company	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product code	HQX · Implant, Orbital, Extra-Ocular
Class	Class 2
FDA submission	K023481
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 22, 2021

Device type (GMDN): Scleral buckling device, non-bioabsorbable

A non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

Other Implant, Orbital, Extra-Ocular devices

Scleral Buckling Products: Style 506, 3.0mm x 5.0mm Oval Sponge 92-50-5
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Implant, Orbital, Extra-Ocular
3 reports

All Implant, Orbital, Extra-Ocular devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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