Monosof N-2770-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521076396), received between Jul 11, 2017 and Jul 9, 2026 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (41 reports).

2 other recalls cover devices cleared under the same FDA submission (K900531); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.

  Patient problems: Tissue Breakdown

  MAUDE report 25759595 ↗
• InjuryJul 9, 2026Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.

  Patient problems: Tissue Breakdown

  MAUDE report 25759594 ↗
• InjuryJul 9, 2026Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.

  Patient problems: Tissue Breakdown

  MAUDE report 25759590 ↗
• InjuryJul 9, 2026Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.

  Patient problems: Tissue Breakdown

  MAUDE report 25759556 ↗
• MalfunctionSep 5, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO AN OPHTHALMIC SURGERY, THE 12 SUTURE THREADS BROKE WITH JUST A SLIGHT TOUCH BEFORE THE STITCHING COULD EVEN BEGIN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975070 ↗
• MalfunctionSep 5, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR AN OPHTHALMIC SURGERY, THE SUTURE THREAD BROKE WITH A SLIGHT TOUCH BEFORE STITCHING BEGAN, AND A COLOR CHANGE OF THE SUTURE WAS OBSERVED. 36 SUTURES FROM THE SAME PRODUCT ID AND LOT WERE INVOLVED, AND ALL ISSUES OCCURRED DURING THE SAME CASE. AN ADDITIONAL NEW SUTURE OF A DIFFERENT LOT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975002 ↗
• MalfunctionSep 5, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR AN OPHTHALMIC SURGERY, THE SUTURE THREAD BROKE WITH A SLIGHT TOUCH BEFORE STITCHING BEGAN, AND A COLOR CHANGE OF THE SUTURE WAS OBSERVED. 36 SUTURES FROM THE SAME PRODUCT ID AND LOT WERE INVOLVED, AND ALL ISSUES OCCURRED DURING THE SAME CASE. AN ADDITIONAL NEW SUTURE OF A DIFFERENT LOT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974943 ↗
• MalfunctionSep 5, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR AN OPHTHALMIC SURGERY, THE SUTURE THREAD BROKE WITH A SLIGHT TOUCH BEFORE STITCHING BEGAN, AND A COLOR CHANGE OF THE SUTURE WAS OBSERVED. 36 SUTURES FROM THE SAME PRODUCT ID AND LOT WERE INVOLVED, AND ALL ISSUES OCCURRED DURING THE SAME CASE. AN ADDITIONAL NEW SUTURE OF A DIFFERENT LOT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974936 ↗
• MalfunctionSep 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMIC SURGERY, THE 24 SUTURES BROKE WITH JUST A SLIGHT TOUCH BEFORE THE STITCHING COULD EVEN BEGIN ON THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968557 ↗
• MalfunctionSep 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMIC SURGERY, THE 24 SUTURES BROKE WITH JUST A SLIGHT TOUCH BEFORE THE STITCHING COULD EVEN BEGIN ON THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967801 ↗
• MalfunctionAug 22, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY; THE THREAD BROKE WITH A SLIGHT PULL. THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874942 ↗
• MalfunctionAug 22, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL. THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874833 ↗
• MalfunctionAug 22, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL. THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874386 ↗
• MalfunctionAug 22, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL. THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874256 ↗
• MalfunctionAug 22, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL. THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874122 ↗
• MalfunctionJul 31, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL AND THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675200 ↗
• MalfunctionJul 31, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE THREAD BROKE WITH A SLIGHT PULL AND THE THREAD COLOR WAS NOT PURE BLACK, APPEARING GOLDEN UNDER MICROSCOPIC OBSERVATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674915 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. IT WAS NOTED THAT THE SUTURE BROKE EASILY WITH MINIMAL USE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649474 ↗
• MalfunctionMar 18, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE SEVERAL TIMES WHEN KNOTTED. THE SUTURE WAS REPLACED AND THE OPERATION CONTINUED, WHICH RESULTING IN PROLONGED THE OPERATION TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633800 ↗
• MalfunctionMar 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMIC CORNEAL TRANSPLANT, THE SUTURE BROKE SEVERAL TIMES WHEN KNOTTED. THE SUTURE WAS REPLACED, AND THE OPERATION CONTINUED. SURGICAL TIME WAS EXTENDED BY ABOUT 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 21632503 ↗
• InjuryMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PTERYGIUM EXCISION AND LIMBAL STEM CELL TRANSPLANTATION IN THE LEFT EYE, WHEN THE 10-0 SUTURE WAS USED TO SUTURE THE CONJUNCTIVAL GRAFT PATCH, THE SUTURE HAD THREAD BREAKAGE FREQUENTLY. THIS RESULTS IN INCREASED SURGICAL TIME OF LESS THAN 10 MINUTES. IT WAS NOTED THAT THERE WAS NO ALTERNATIVE SUTURE, CONTINUED TO USE THE CURRENT SUTURE. IMMEDIATELY AFTER THE PROCEDURE, IT WAS NOTED THAT TOO MANY KNOTS CAUSED DISCOMFORT IN THE PATIENT'S EYE AFTER THE SURGERY. TO RESOLVE THE ISSUE, THE SURGEON RE-OPERATED AND USED A NEW SUTURE.

  Patient problems: Eye Irritation; No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 21602744 ↗
• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PTERYGIUM EXCISION AND LIMBAL STEM CELL TRANSPLANTATION IN THE LEFT EYE, WHEN THE CONJUNCTIVAL GRAFT WAS SUTURED, THE SUTURE BROKE FREQUENTLY. THE SURGERY WAS EXTENDED BY LESS THAN 10 MINUTES DUE TO PRODUCT ISSUE. THERE WAS NO ALTERNATIVE SUTURE, AND CONTINUED TO USE THE CURRENT SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599232 ↗
• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER, IN THE POSTOPERATIVE PERIOD OF A TRABECULECTOMY, AT THE NEXT DAY'S FOLLOW-UP, THE SUTURE APPLIED DURING C ONJUNCTIVAL CLOSURE BROKE AND CAUSED A LEAKY WOUND. THE SURGEON APPLIED A CONTACT LENS, AND TREATED THE PATIENT WITH TOPICAL ANTIBIOTICS AND AN AQUEOUS HUMOR SUPPRESSANT. THE PATIENT WILL RETURN TO THE PHYSICIAN AND MAY NEED A REPAIR OF THE CONJUNCTIVA WITH ANOTHER STITCH.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 21590778 ↗
• MalfunctionSep 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AND THE NEEDLE CAME OFF, WHICH CAUSED HAVING TO USE SEVERAL SUTURES FOR THE SAME PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304393 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY SURGERY, PENETRATING OCULAR INJURY WITH FULL THICKNESS CORNEAL INJURY, THE SUTURE WAS EASILY CUT ON MULTIPLE OCCASIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303871 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX
• Z-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10