MERSILENE 1722GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031002265), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K946173); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Material Separation; Material Separation

  THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF VOLUNTARY MEDWATCH REPORT (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY (B)(6) 2018 FOR RIGHT UPPER LID PTOSIS REPAIR AND SUTURE WAS USED. THE SUTURE WAS USED TO MAKE A PARTIAL THICKNESS PASS THROUGH THE TARSAL PLATE. THE SUTURE WAS THEN BROUGHT OUT THROUGH THE LEVATOR APONEUROSIS SUPERIORLY APPROXIMATELY 15 MM SUPERIOR TO ITS ORIGINAL POSITION. THE SUTURE WAS TIED TEMPORARILY IN PLACE. THE LID HEIGHT AND CONTOUR WERE INSPECTED AND THE SUTURE WAS ADJUSTED AS NEEDED TO PRELIMINARILY ACHIEVE THE DESIRED LID HEIGHT AND CONTOUR. AS THE MEDIAL END OF THE SUTURE WAS BEING PASSED, IT WAS NOTED THAT THE NEEDLE WAS NOT ATTACHED TO THE CORRESPONDING END OF THE SUTURE. THE OPERATIVE SITE WAS EXPLORED AND THE NEEDLE WAS NOT LOCATED. A DETAILED SEARCH OF THE DRAPES AND THE FLOOR AND AREA SURROUNDING THE OPERATING ROOM TABLE DID NOT LOCATE THE NEEDLE. RADIOLOGY WAS CONSULTED AND THE X-RAY REVEALED "A NEEDLE FOREIGN BODY IS PRESENT IN THE POSTOPERATIVE RIGHT EYELID. THIS MEASURES APPROXIMATELY 6.5 MM IN LENGTH, IS LOCATED 6 MM DEEP TO THE ANTERIOR SKIN OF THE RIGHT EYELID AND EXTENDS TO NEAR THE POSTERIOR ASPECT OF THE EYELID AT APPRO

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8317927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.