Polysorb L-2748KRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521046498), received between Sep 19, 2022 and May 14, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD BROKE WHEN THE SUTURE WAS UNPACKED FOR INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019924 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EYE PROCEDURE, THE PACKAGE WAS OPENED, AND IT WAS DISCOVERED THAT THE TWO SUTURE THREADS WERE BROKEN. THE THREADS BROKE UPON TOUCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936490 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EYE PROCEDURE, THE PACKAGE WAS OPENED, AND IT WAS DISCOVERED THAT THE TWO SUTURE THREADS WERE BROKEN. THE THREADS BROKE UPON TOUCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936453 ↗
• MalfunctionMar 25, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN USING THE SUTURE TO SUTURE THE PATIENT'S SCLERAL PUNCTURE AND TYING A KNOT, THE SUTURE BROKE ABNORMALLY, CAUSING THE PATIENT'S INTRAOCULAR FLUID TO FLOW OUT. EMERGENCY CLOSURE OF THE PUNCTURE AND RE-SUTURE WAS PERFORMED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THERE WAS DELAYED TREATMENT AS A RESULT.

  Patient problems: Fluid Discharge

  MAUDE report 21685731 ↗
• MalfunctionMar 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE WHILE SUTURING THE SCLERAL PUNCTURE SITE. THE PATIENT'S INTRAOCULAR FLUID FLOWED OUT AND THE PUNCTURE WAS IMMEDIATELY CLOSED AND A NEW SUTURE WAS USED TO RESOLVED THE ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY TEN MINUTES.

  Patient problems: Fluid Discharge

  MAUDE report 21685589 ↗
• MalfunctionMar 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS SUTURING THE SCLERAL PUNCTURE, THE SUTURE WAS ABNORMALLY BROKEN. TO RESOLVE THE ISSUE, THE PUNCTURE WAS URGENTLY CLOSED AND SUTURED AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 21567180 ↗
• MalfunctionJan 22, 2025Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY TO THE LEFT EYE VITRECTOMY SILICONE OIL REMOVAL, THE SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS OPENED AND FOUND TO HAVE NATURALLY DEGRADED INTO MULTIPLE SEGMENTS AND CANNOT BE USED ON THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21208227 ↗
• MalfunctionJan 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMIC WOUND PROCEDURE, THE NEEDLE BROKE NEAR THE NEEDLE TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065257 ↗
• MalfunctionNov 26, 2024Break; Break

  ACCORDING TO THE REPORTER, WHEN THE SURGERY WAS ALMOST OVER, WHILE SUTURING THE RIGHT EYE CONJUNCTIVA, IT WAS FOUND THAT THE NEEDLE WAS BROKEN. THE SUTURE COULD NOT BE INSERTED. THE PROCEDURE WAS IMMEDIATELY STOPPED, AND THE BROKEN END OF THE SUTURE WAS SEARCHED FOR. THE BROKEN END WAS FOUND ON THE PATIENT'S CONJUNCTIVAL SAC. THE BROKEN NEEDLE AND THE REMAINING PART OF THE NEEDLE WERE COLLECTED. AFTER CONFIRMING THAT THERE WAS NO OTHER RESIDUE, THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE FINAL SUTURE, AND THE SURGERY WAS OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786270 ↗
• MalfunctionOct 30, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN OPHTHALMIC STRABISMUS SURGERY, THE CONJUNCTIVA WAS SUTURED AND THE SUTURE BROKE JUST AFTER IT WAS ENTERED. A NEW SUTURE WAS USED TO CONTINUE THE SUTURING AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574791 ↗
• MalfunctionOct 30, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, THE USER OPENED THE OUTER PACKAGING OF THE THREE SUTURES AND FOUND THAT ALL THREE SUTURES HAD BROKEN AT A TOUCH BEFORE STARTING TO SEW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567189 ↗
• MalfunctionOct 30, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO AN EYE SURGERY, THE USER OPENED THE OUTER PACKAGING OF THE THREE SUTURES AND FOUND THAT ALL THREE SUTURES HAD BROKEN AT A TOUCH BEFORE STARTING TO SEW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566902 ↗
• MalfunctionOct 30, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO AN EYE SURGERY, THE USER OPENED THE OUTER PACKAGING OF THE THREE SUTURES AND FOUND THAT ALL THREE SUTURES HAD BROKEN AT A TOUCH BEFORE STARTING TO SEW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566742 ↗
• MalfunctionJan 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, DURING VITREOUS STITCHING, THE NEEDLE BROKE. NO DEVICE COMPONENT FELL INTO CAVITY OF PATIENT. THE WIRE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552052 ↗
• MalfunctionSep 19, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE BROKE. A NEW SUTURE USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452030 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI