Devices › Suture, nonabsorbable, synthetic, polyamide
Device brand name · Suture nonabsorbable synthetic polyamide
Alcon Closure System (ACS), Nylon: medical device reports filed with FDA
323 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Alcon Precision Device. Product code GAR.
- 323
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 152
- reports, 12 months to August 2026
- 89 in the 12 months before
- 90.1%
- classified as malfunction
- 84.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 323 reports that name the brand "Alcon Closure System (ACS), Nylon" (suture nonabsorbable synthetic polyamide), received between March 2015 and August 2026; the manufacturer given most often on reports is Alcon Research - Alcon Precision Device. Spellings of one product vary from report to report.
152 reports arrived in the 12 months to August 2026, up 71% from 89 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (90.1%) and injury (9.9%); across all suture, nonabsorbable, synthetic, polyamide reports (product code GAR) death is recorded in 0% and malfunction in 84.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (50.8%), dull, blunt (43%) and material split, cut or torn (5.3%). The patient problems coded most often are hyperemia, red eye(s) and appropriate clinical signs, symptoms and conditions term/code not available. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,142 reports carrying product code GAR. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 164 | 50.8% | 45.5% |
| Dull, blunt | 139 | 43% | 3% |
| Material split, cut or torn | 17 | 5.3% | 2.2% |
| Crackthe device cracked | 10 | 3.1% | 0.2% |
| Material discolored | 8 | 2.5% | 0.4% |
| Material too soft/flexible | 5 | 1.5% | 0.1% |
| Packaging problem | 2 | 0.6% | 0.3% |
| Unexpected color | 2 | 0.6% | 0% |
| Unsealed device packaging | 2 | 0.6% | 0.2% |
| Defective devicethe device was defective | 1 | 0.3% | 0% |
| Material separation | 1 | 0.3% | 21.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperemia | 6 | 1.9% |
| Red eye(s) | 6 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 1.5% |
| Corneal edema | 4 | 1.2% |
| Conjunctivitispink eye | 3 | 0.9% |
| Discomfortdiscomfort | 3 | 0.9% |
| Wound dehiscencea wound reopened | 3 | 0.9% |
| Calcium deposits/calcification | 1 | 0.3% |
| Conjunctival hemorrhage | 1 | 0.3% |
| Eye injury | 1 | 0.3% |
| Inflammationinflammation | 1 | 0.3% |
| Intraocular pressure increasedraised pressure in the eye | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alcon Closure System (ACS), Nylon | Product code GAR | All MAUDE reports |
|---|---|---|---|
| Reports | 323 | 6,142 | 26,136,888 |
| Share of that pool | — | 5.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 9.9% | 14.7% | 36.2% |
| Classified as malfunction | 90.1% | 84.9% | 62.3% |
| Filed by the manufacturer | 100% | 98.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code GAR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Monosof | 410 | 89 | 0% |
| ETHILON Nylon Suture | 403 | 9 | 0.2% |
| Ethilon Nylon Suture Unknown Product | 191 | 6 | 0.5% |
| Ethilon | 186 | 183 | 0% |
| Non Absorbable Surgical Suture | 337 | 39 | 0% |
| McKesson | 446 | 74 | 0% |
| Unknown Suture Product | 448 | 28 | 0.9% |
| ETHIBOND Extra & Excel Polyester Suture | 317 | 34 | 0% |
| Surgicel Absorbable Hemostat | 289 | 0 | 2.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Alcon Closure System (ACS), Nylon reports
How many FDA reports name Alcon Closure System (ACS), Nylon?
323 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 152 in the latest 12 months.
What kinds of events are reported?
malfunction (90.1%) and injury (9.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (50.8%), dull, blunt (43%), material split, cut or torn (5.3%), crack (3.1%) and material discolored (2.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Alcon Closure System (ACS), Nylon was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.