PROLENE 9090GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031022645), received between Sep 25, 2019 and Mar 20, 2020 — classified as 1 injury, 1 malfunction.

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

21 other recalls cover devices cleared under the same FDA submission (K133356); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: A MODIFIED IRIS SUTURE TECHNIQUE FOR IN-THE-BAG INTRAOCULAR LENS DISLOCATION. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO DESCRIBE A MODIFIED IRIS SUTURE TECHNIQUE OF DISPLACED, IN-THE-BAG, ONE- AND THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOLS) THAT MINIMIZES OPERATIVE COMPLEXITY AND CIRCUMVENTS THE NEED FOR SECONDARY LENS EXPLANTATION AND REPLACEMENT. A TOTAL OF 94 EYES WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 83.5 YEARS (RANGE: 74¿99 YEARS). ALL UNDERWENT SURGERY FOR REPOSITIONING OF LATE, POSTERIORLY DISLOCATED, IN-THE BAG PCIOLS USING AN IRIS SUTURE FIXATION TECHNIQUE FROM APRIL 2009 TO NOVEMBER 2015. A SINGLE-ARMED 10-0 POLYPROPYLENE SUTURE ON A CIF-4 OR CTC-6 NEEDLE (ETHICON, INC, SOMERVILLE,NJ), AND VERY WIDE SUTURE LOOP WAS USED. A WIDE PASS IS USED TO INCLUDE THE HAPTIC. TWO CASES OF VITREOUS HEMORRHAGE OCCURRED AND WERE BOTH CLEARED SPONTANEOUSLY. TWO PATIENTS HAD CYSTOID MACULAR EDEMA AND WERE TREATED WITH TOPICAL MEDICATION. TWO PATIENTS DEVELOPED MALIGNANT GLAUCOMA AND NEEDED AN IRIDECTOMY WITH ANTERIOR CHAMBER REFORMATION. THE AUTHORS CONCLUDED THAT THIS SIMPLE AND SAFE IRIS SUTURE TECHNIQUE

  Patient problems: Edema; Eye Injury; Hemorrhage/Blood Loss/Bleeding; Not Applicable

  MAUDE report 9861081 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD WAS CUT OFF WHILE USING THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.