Aurolon
AUROLAB · Model 8481N · UDI-DI 00803878028899
1
510(k) clearances
6,142
Adverse events (2 deaths)
14
Recalls
116
Facilities
Description
Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 8481N model consists of a 8/0 Nylon suture of length 40cm attached with one 200 microns SS needles having the needle length of 6.0mm in one end of suture. Angle of curvature of the needle is 140° [3/8 Circle]. Point profile of needle is Spatula.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2025-01-27 | TAS Medical Inc | Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F steri |
| 2023-12-21 | Covidien LP | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could r |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2016-08-05 | Riverpoint Medical, LLC | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| 2016-08-05 | Riverpoint Medical, LLC | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| 2014-06-13 | Aesculap, Inc. | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.