Sofport Easy-Load Lens Delivery System EZ-24Recalls & reported problems
Bausch & Lomb Incorporated · Inserter - Lens Delivery System · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00757770529032), received between May 4, 2023 and Apr 22, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information6
- Capsular Bag Tear5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Vitreous Loss1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL), THE HAPTIC BECAME STUCK IN THE INJECTOR AND WAS AMPUTATED. THE LENS WAS REMOVED AND THE INCISION WAS ENLARGED. A REPLACEMENT IOL OF THE SAME MODEL AND POWER WAS PLACED, AND A SUTURE WAS REQUIRED. THE PATIENT IS EXPECTED TO EXPERIENCE A PROLONGED RECOVERY PERIOD; HOWEVER, THE OVERALL PROGNOSIS IS EXCELLENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24955895 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGICAL CENTER REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENTS LEFT EYE A CAPSULAR TEAR OCCURRED UPON EJECTION OF THE LENS. WHEN THE IOL WAS INSERTED INTO THE EYE, THE DOCTOR NOTICED THE LEADING HAPTIC WAS OVER THE OPTIC. AS HE TRIED TO FIX THE LENS, A TEAR WAS CREATED IN THE CAPSULAR BAG. THE LENS WAS EXPLANTED, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A BACKUP LENS WAS SUCCESSFULLY PLACED. PER THE REPORT THE PATIENT IS EXPECTED TO MAKE A FULL VISUAL RECOVERY.
Patient problems: Capsular Bag Tear
MAUDE report 22145321 ↗InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, A "PC OPENING" OCCURRED DURING CATARACT SURGERY ON THE LEFT EYE AND A VITRECTOMY WAS PERFORMED. THE IOL WAS REPLACED WITH A DIFFERENT MODEL AND POWER IOL.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 18668537 ↗InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANTATION PROCESS OF AN IOL INTO THE LEFT EYE AN ANTERIOR VITRECTOMY HAD TO BE PERFORMED AND THE LENS WAS NOT PLACED. PATIENT LEFT APHAKIC. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18659484 ↗InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AN IOL WAS REMOVED FROM THE LEFT EYE AND REPLACED WITH A BACKUP OF THE SAME MODEL AND DIOPTER. THE REASON FOR THIS LENS EXCHANGE IS UNKNOWN. THE INCISION WAS ENLARGED. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18659320 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY AN INTRA-OP IOL EXCHANGE WAS PERFORMED IN THE RIGHT EYE SULCUS. VITRECTOMY WAS NEEDED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18656147 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A CAPSULAR TEAR OCCURRED. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 18656127 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO A CAPSULE TEAR IN THE RIGHT EYE, THE INTRAOCULAR LENS (IOL) WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 18655834 ↗InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IOL OPTIC WAS SCRATCHED DURING LOADING INTO THE INSERTER AND IMPLANTING IN THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND LENS WAS REPLACED WITH A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. A SUTURE WAS USED TO CLOSE THE WOUND. THE PATIENT HAS RECOVERED FROM SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18545078 ↗InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE PERFORMING A COMBINED INTRAOCULAR LENS (IOL) EXCHANGE AND VITRECTOMY PROCEDURE, DURING IMPLANTATION OF THE IOL INTO THE LEFT EYE, IT WAS OBSERVED THAT THE LEADING HAPTIC WAS BENT BEYOND REPAIR. THE IOL WAS REMOVED. SMALL ZONULAR DIALYSIS WAS OBSERVED WITH VITREOUS LOSS. A VITRECTOMY WAS PERFORMED, AND A SUCCESSFUL LENS EXCHANGE WAS PERFORMED POSITIONING A BACKUP THREE-PIECE LENS IN THE CILIARY SULCUS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE IOL DAMAGE WAS THE DELIVERY DEVICE WHICH ALLEGEDLY LED TO THE BENT HAPTIC. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Vitreous Loss
MAUDE report 17184871 ↗InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED INTRAOPERATIVELY DUE TO AN UNSTABLE CAPSULE. THE PATIENT REQUIRED A VITRECTOMY AND WAS LEFT APHAKIC. IT WAS REPORTED AN ANTERIOR PLACEMENT WILL BE NEEDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 16867546 ↗
Other Folders And Injectors, Intraocular Lens (Iol) devices
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- BLIS-X1Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)23 reports
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- RxSight Insertion Device 63002Rxsight, Inc. · Folders And Injectors, Intraocular Lens (Iol)17 reports
- RxSight Injector Handpiece 63001Rxsight, Inc. · Folders And Injectors, Intraocular Lens (Iol)9 reports
- Bausch + Lomb BLIS-R1Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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