UNFOLDER PLATINUM 1 SERIES 1MTEC30Recalls & reported problems

Summary

The FDA's MAUDE database contains 524 adverse event reports that list this exact device (DI 05050474540323), received between Aug 26, 2016 and Jun 12, 2026 — classified as 49 injuries, 475 malfunctions.

The most frequently reported specific device problem is “Crack” (127 reports).

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 524 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break; Crack; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER THAT THE NON PRELOADED INTRAOCULAR LENSES(IOLS) WERE FOUND DAMAGED INSIDE THE CARTRIDGES, RENDERING THEM UNABLE TO BE INJECTED AND REQUIRING REPLACEMENT WITH NEW LENSES. ALL AFFECTED CARTRIDGES WERE IDENTIFIED AS BELONGING TO THE SAME LOT. IT WAS NOTED THAT THE DAMAGE OCCURRED WHILE THE LENSES WERE FULLY INSIDE THE CARTRIDGES, WITH NO CONTACT MADE BETWEEN THE LENSES AND THE PATIENTS' EYES, RESULTING IN NO ADVERSE EFFECTS FOR THE PATIENTS. ADDITIONAL INFORMATION INDICATED THAT A CRACK IN THE CARTRIDGE HAD FALLEN ONTO THE IOL AFTER IMPLANTATION AND THE TIP OF THE CARTRIDGE HAD BEEN BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINED TO ONE OF THE THREE CARTRIDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491904 ↗
• InjuryJun 3, 2026Break

  IT WAS REPORTED THAT A NON-PRELOADED THREE-PIECE LENS WAS LOADED INTO A BUTTERFLY INJECTOR. HIGH PRESSURE WAS NOTED DURING DELIVERY, AND THE TRAILING HAPTIC KINKED. A POSTERIOR CAPSULE RENT OCCURRED, AND THE LENS WAS SUBSEQUENTLY EXPLANTED. A VITRECTOMY WAS PERFORMED, AND MEDICATIONS WERE PRESCRIBED FOR THE POSTERIOR CAPSULE RENT COMPLICATIONS. THE PROCEDURE WAS DELAYED BY 30 MINUTES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25383710 ↗
• MalfunctionMay 13, 2026Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE FRONT PORTION OF THE IOL CARTRIDGE WAS FOUND TO BE BROKEN. THE OPERATION WAS IMMEDIATELY STOPPED, A QUALIFIED IOL FOLDING FORCEPS WAS USED TO REPLACE IT, THE SURGERY PROCEEDED SMOOTHLY, AND NO HARM WAS CAUSED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162961 ↗
• MalfunctionApr 11, 2026Crack; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, AND WAS TIGHT IN THE CARTRIDGE, CAUSING THE CARTRIDGE TO BURST AND RESULTING IN A CHIP ON THE BACK SURFACE OF THE IOL. THE IOL OPENED MORE SLOWLY THAN USUAL, AND THE CHIP WAS LOCATED IN THE UPPER EYELID AREA. THE MAIN TUNNEL INCISION WAS NOT DAMAGED BY THE RUPTURED CARTRIDGE. THE SURGEON HAD TO APPLY ADDITIONAL PRESSURE TO PUSH THE IOL THROUGH THE CARTRIDGE NOZZLE AS THE HAPTICS WERE STUCK BETWEEN THE PLUNGER AND THE CARTRIDGE NOZZLE. THE PLUNGER WAS MOVING WITH DIFFICULTY. THE SURGEON EXPRESSED CONCERN THAT THE LENS DID NOT FULLY OPEN, DID NOT BECOME FLAT, AND HAD DENTS ON ITS SURFACE. EARLY POSTOPERATIVE TREATMENT RESULTS WERE SATISFACTORY. NO ADDITIONAL PATIENT OUTCOMES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A REPORT IS BEING FILED AGAINST THE LENS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848864 ↗
• MalfunctionMar 25, 2026Crack

  IT WAS REPORTED THAT UNFOLDER PLATINUM CARTRIDGE WAS DAMAGED AFTER IMPLANTATION. THE DAMAGE WAS NOTED DURING IMPLANTATION/APPLICATION. NO PATIENT OR USER HARM OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690583 ↗
• MalfunctionNov 11, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE WAS FOUND BROKEN AFTER INSERTION OF THE INTRAOCULAR LENS (IOL). ACCOUNT INDICATED THAT THE BROKEN CARTRIDGE PIECE LIED ON TOP OF THE IOL INSIDE THE ANTERIOR CHAMBER AND THE BROKEN PIECE WAS REMOVED WITHOUT FURTHER COMPLICATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529324 ↗
• MalfunctionNov 7, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT THE LENS CARTRIDGE (1MTEC30) WAS DEFECTIVE. THE ISSUE WAS IDENTIFIED DURING A SURGICAL PROCEDURE WHEN A SMALL PLASTIC DEFECT WAS REMOVED FROM THE PATIENT¿S EYE; HOWEVER, NO PATIENT INJURY WAS REPORTED. THIS WAS THE SECOND OCCURRENCE OF THIS ISSUE ON THE SAME DAY. NO FURTHER INFORMATION PROVIDED. THE ISSUE WAS REPORTED WITH TWO (2) CARTRIDGES. THIS MDR REPORT IS TWO (2) OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501602 ↗
• MalfunctionNov 7, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT THE LENS CARTRIDGE (1MTEC30) WAS DEFECTIVE. THE ISSUE WAS IDENTIFIED DURING A SURGICAL PROCEDURE WHEN A SMALL PLASTIC DEFECT WAS REMOVED FROM THE PATIENT¿S EYE; HOWEVER, NO PATIENT INJURY WAS REPORTED. THIS WAS THE SECOND OCCURRENCE OF THIS ISSUE ON THE SAME DAY. NO FURTHER INFORMATION PROVIDED. THE ISSUE WAS REPORTED WITH TWO (2) CARTRIDGES. THIS MDR REPORT IS ONE (1) OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501599 ↗
• MalfunctionOct 17, 2025Crack; Crack

  IT WAS REPORTED THAT WHEN ADVANCING LENS THROUGH THE TIP OF THE CARTRIDGE, THE CARTRIDGE TIP SPLIT. CARTRIDGE LOADED WITH VISCO AND LENS AS USUAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325924 ↗
• MalfunctionOct 15, 2025Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2025, DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE USING AN UNFOLDER PLATINUM SERIES CARTRIDGE, A PLASTIC REMNANT WAS FOUND ON THE TRAILING HAPTIC OF THE IOL AFTER IT WAS INJECTED INTO THE EYE. THE SURGEON SUCCESSFULLY REMOVED THE PLASTIC REMNANT DURING THE PROCEDURE, AND THE IOL WAS IMPLANTED WITHOUT COMPLICATIONS. THE ISSUE DID NOT IMPACT THE PATIENT, AND THERE WAS NO DELAY IN THE PROCEDURE, NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED, AND NO ADVERSE EFFECTS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296309 ↗
• MalfunctionOct 15, 2025Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF A 1MTEC30 CARTRIDGE BROKE WHILE THE LENS WAS BEING INJECTED INTO THE PATIENT'S EYE. THIS CAUSED A SMALL PIECE OF PLASTIC TO DETACH AND ENTER THE PATIENT¿S EYE. THE SURGEON REMOVED THE DETACHED PLASTIC PIECE SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286053 ↗
• MalfunctionJul 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT A SHARP, PLASTIC JAGGED SHARD OF PLASTIC SEEMED TO COME OUT OF THE CARTRIDGE ALONG WITH THE LENS AND WAS INTRODUCED INTO THE PATIENT'S LEFT EYE. THE FOREIGN MATERIAL WAS SUCCESSFULLY REMOVED FROM THE EYE WITHOUT ANY REPORTED PATIENT INJURY. THE SHARD OF PLASTIC WAS NOTED TO HAVE BEEN PRESENT INSIDE THE PRODUCT PACKAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496543 ↗
• MalfunctionJul 8, 2025Crack; Crack

  IT WAS REPORTED THAT CARTRIDGE TIP WAS DAMAGED AND CAUSED CORNEAL SCRATCH ON PATIENT EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Corneal Abrasion

  MAUDE report 22448097 ↗
• MalfunctionApr 24, 2025Contamination; Contamination

  IT WAS REPORTED THAT A FOREIGN BODY WAS FOUND AFTER FOLDING THE NON-PRELOADED INTRAOCULAR LENS (IOL) AND INSERTED TO PATIENT¿S EYE. THE FOREIGN BODY WAS THEN REMOVED BY SURGEON. PATIENT WAS NOT AFFECTED. AS PER ADDITIONAL INFORMATION RECEIVED, NO PATIENT FACTOR CONTRIBUTED TO THIS EVENT. THERE WAS NO USE ERROR BY PHYSICIAN DURING THE PROCEDURE. RIGHT EYE WAS AFFECTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR CARTRIDGE. ANOTHER REPORT IS SUBMITTED FOR LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906046 ↗
• MalfunctionMar 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT WHEN USING THE CARTRIDGE TO IMPLANT THE LENS, WHITE PARTICLES WERE OBSERVED AFTER LENS INJECTION. THE PARTICLES WERE REMOVED WITH IRRIGATION AND ASPIRATION AND THE PATIENT IS REPORTED AS FULLY RECOVERED. THROUGH FOLLOW UP, WE LEARNED THAT IT IS NOT KNOWN IF THE PARTICLES AROSE FROM THE CARTRIDGE. THERE WAS NO DELAY TO THE PROCEDURE. THERE ARE NO PHOTOGRAPHS OR VIDEOS AVAILABLE TO INVESTIGATE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612918 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098994 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098987 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098980 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER: 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098962 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098957 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098941 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098923 ↗
• MalfunctionJan 8, 2025Contamination; Contamination

  IT WAS PREVIOUSLY REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PLATINUM CARTRIDGES ARE LEAVING A FILMY OR STICKY SUBSTANCE ON THE BOTTOM SIDE OF THE LENS WHEN IMPLANTING. (MANUFACTURER REPORT NUMBER 3012236936-2024-00697). PRESENTLY, THE SURGEON HAS CONTINUED TO NOTICE THE FILMY SUBSTANCE FROM THE COATING ON THE LENS MORE AND MORE. THE JOHNSON AND JOHNSON ACCOUNT EXECUTIVE JOINED THE CUSTOMER FOR SEVERAL CASES AND NOTICED THE FILMY SUBSTANCE ON 8 CASES. THE FILMY SUBSTANCE GETS STUCK ON THE BOTTOM SIDE OF THE IOL AND THE SURGEON USES HIS IRRIGATION/ASPIRATION (I/A) TO CLEAR IT, REMOVE IT. THE JNJ ACCOUNT EXECUTIVE FOLLOWED WHAT THE TECHNICIANS WERE DOING, AND IT WAS NOTHING OUT OF THE ORDINARY. THE CUSTOMER USES HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHILE LOADING THE IOL. IN A FEW CASES THEY TRIED FLUSHING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) PRIOR TO OVD TO SEE IF THAT WOULD FLUSH IT OUT. REPORTEDLY, THE CUSTOMER TRIED JUST ABOUT EVERYTHING. THE DOCTOR POINTED OUT THE SUBSTANCE WHICH WAS VISIBLE ON THE MONITOR IN THE OPERATING ROOM (OR) BUT NO PHOTOS OR VIDEOS WERE TAKEN. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURE REQUIRED. NOTE: THE PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098893 ↗
• MalfunctionDec 30, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS CARTRIDGE TIP CRACKED WHEN THE INTRAOCULAR LENS WAS IMPLANTED TO THE PATIENT'S EYE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044100 ↗
• MalfunctionDec 4, 2024Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) GOT STUCK IN THE MIDDLE OF THE INCISION AND PRESENTED A LOT OF RESISTANCE TO THE IMPLANT. THE PHYSICIAN HAD TO CAREFULLY ENLARGE THE INCISION TO DELIVER THE IOL. PHOTOGRAPH ATTACHED SHOWS CARTRIDGE TIP DAMAGED. THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP, WE LEARNED, THAT A SUPPLEMENTAL IOL WAS IMPLANTED AND THE PATIENT WAS FINE IMMEDIATELY AFTER SURGERY AND NO ADDITIONAL MEDICATION WAS REQUIRED TO BE ADMINISTERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20849437 ↗