SofPort IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 20 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 20 models of SofPort IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jan 22, 2020 and Apr 22, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Material Twisted/Bent” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SofPort IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Material Twisted/Bent7
- Device Dislodged or Dislocated6
- Failure to Eject3
- Break2
- Material Split, Cut or Torn2
- Material Integrity Problem1
- Material Opacification1
Patient problems
- Insufficient Information8
- Capsular Bag Tear7
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Scar1
- Eye Pain1
- Halo1
SofPort IOL models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SofPort® IOL LI61AOIntraocular Lens5 reports
- SofPort® IOL LI61AOIntraocular Lens3 reports
- SofPort® IOL LI61AOIntraocular Lens2 reports
- SofPort® IOL LI61AOIntraocular Lens2 reports
- SofPort® IOL LI61AOIntraocular Lens2 reports
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
- SofPort® IOL LI61AOIntraocular Lens1 report
Recent SofPort IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Material Split, Cut or Torn
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 24955880 ↗InjuryDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING PHACOEMULSIFICATION OF THE RIGHT EYE (OD), A CAPSULE RUPTURE OCCURRED. THE SURGEON ATTEMPTED TO IMPLANT AN INTRAOCULAR LENS (IOL) INTO THE SULCUS AND A BENT HAPTIC WAS OBSERVED. THE INCISION WAS ENLARGED TO REMOVE THE IOL, A VITRECTOMY WAS PERFORMED, THE PATIENT WAS LEFT APHAKIC, AND THE WOUND WAS CLOSED WITH SUTURES. THE PATIENT IS EXPECTED TO RETURN AT A LATER DATE FOR IOL IMPLANTATION. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS A LOADING ERROR. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 23704942 ↗InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PIGGYBACK IOL WAS REPOSITIONED ON THE SAME DATE DECENTRATION WAS OBSERVED AND 10 DAYS POST-INTERVENTION IT WAS DETERMINED THE INITIAL AND PIGGYBACK LENS WOULD BOTH BE REMOVED TO REPLACE WITH THE DIFFERENT POWER IOL.
Patient problems: Visual Disturbances
MAUDE report 22921322 ↗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 22145269 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE LEFT EYE THE INJECTOR PLUNGER SHOT FORWARD WHEN IN THE EYE AND THERE WAS A POSTERIOR CAPSULE (PC) TEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL WITH THE SAME MODEL AND POWER. THE PATIENT WAS PROVIDED WITH THE GLAUCOMA PROTOCOL. ADDITIONAL TREATMENT WAS NOT REQUIRED. ADDITIONAL INFORMATION IS NOT AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 22102971 ↗InjuryApr 2, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A BENT HAPTIC WAS NOTICED. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE IOL, A BACK UP LENS WAS IMPLANTED, AND THE WOUND WAS CLOSED WITH NYLON SUTURES. OUTCOME OF THE PATIENT IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752080 ↗InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE IOL DISLOCATED AND AN UNCOMPLICATED LENS EXCHANGE WAS PERFORMED USING A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21397427 ↗InjuryFeb 5, 2025Break; Break
IT WAS REPORTED APPROXIMATELY THREE MONTHS AFTER IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH BLURRY VISION. THE SURGEON REPORTED AN IOL FRAGMENT WAS OBSERVED ON THE ANTERIOR SURFACE. A SUCCESSFUL LENS EXCHANGE WAS COMPLETED. IN THE SURGEON'S OPINION, THE CAUSE OF THE EVENT IS UNKNOWN, AND THE PATIENT'S OUTCOME IS GOOD.
Patient problems: Blurred Vision
MAUDE report 21312343 ↗InjuryNov 18, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THREE DAYS AFTER THE IMPLANTATION OF AN INTRALOCULAR LENS(IOL), INTO THE RIGHT EYE (OD), A SUCCESSFUL LENS EXCHANGE USING A DIFFERENT MODEL IOL WAS COMPLETED DUE TO DISLOCATION OF THE IOL. A VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 20717523 ↗InjuryNov 18, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRALOCULAR LENS(IOL) INTO THE EYE, THE IOL APPEARED TO BE PASSING THROUGH THE INJECTOR CARTRIDGE SLIGHTLY TILTED, CAUSING THE LEADING HAPTIC TO BE PUSHED POSTERIORLY BY THE ANTERIOR PORTION OF THE INJECTOR AND THROUGH THE CAPSULE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 20707730 ↗InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 3 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00119 AND 0001313525-2024-00120.
Patient problems: Insufficient Information
MAUDE report 19787559 ↗InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 1 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00120 AND 0001313525-2024-00121.
Patient problems: Insufficient Information
MAUDE report 19787558 ↗InjuryJul 20, 2024Failure to Eject; Failure to Eject
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS LENS 2 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00119 AND 0001313525-2024-00121.
Patient problems: Insufficient Information
MAUDE report 19787557 ↗InjuryApr 18, 2024Material Twisted/Bent; Material Twisted/Bent
REPORTEDLY, DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, IT WAS NOTICED THAT A HAPTIC WAS BENT. THE INCISION WAS ENLARGED, THE IOL WAS REMOVED, AND A BACKUP LENS WAS IMPLANTED WITH NO ADVERSE EVENT NOTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19134459 ↗InjuryMar 19, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATIVELY 15 YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS(IOL), THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. ACCORDING TO THE SURGEON, THE LENS WAS OUT OF POSITION DUE TO A DISLOCATED RETINA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18933279 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Toric IOL450 models · 15 reports · 2 recalls
- enVista Envy IOL53 models · 52 reports · 1 recall
- enVista Envy Toric IOL513 models · 39 reports · 1 recall
- enVista Aspire IOL57 models · 10 reports · 1 recall
- Akreos IOL8 models · 10 reports · 1 recall
- enVista Aspire Toric IOL513 models · 8 reports · 1 recall
- IC-8 Apthera IOL20 models · 38 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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