Polycryl
AUROLAB · Model A6108 · UDI-DI 00803878029025
1
510(k) clearances
57,611
Adverse events (88 deaths)
130
Recalls
144
Facilities
Description
Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6108 model consists of a 6/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both the ends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are 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 |
| 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 |
| 2024-09-25 | Ethicon, Inc. | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the pack |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-03-26 | SURGICAL SPECIALTIES | Complaints have been received with allegations of Incorrect Needle Curvature. |
| 2024-03-08 | Ethicon, Inc. | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility |
| 2022-09-28 | Covidien, LP | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the ne |
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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.