SMARTLOADRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 231
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls
- 0
We found 52 models of SMARTLOAD by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 231 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2019 and Sep 22, 2026 — classified as 42 injuries, 189 malfunctions.
The most frequently reported specific device problem is “Break” (83 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 SMARTLOAD problems
Device problems
- Break83
- Contamination42
- Adverse Event Without Identified Device or Use Problem40
- Crack18
- Scratched Material15
- Material Fragmentation10
- Material Opacification10
- Device Difficult to Setup or Prepare9
Patient problems
- No Clinical Signs, Symptoms or Conditions184
- Endophthalmitis13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Toxic Anterior Segment Syndrome (TASS)6
- Eye Infections5
- Hyphema4
- Intraocular Pressure Increased3
- Capsular Bag Tear2
SMARTLOAD models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SMARTLOAD GCB00intraocular lens15 reports
- SMARTLOAD GCB00intraocular lens13 reports
- SMARTLOAD GCB00intraocular lens13 reports
- SMARTLOAD GCB00intraocular lens12 reports
- SMARTLOAD GCB00intraocular lens12 reports
- SMARTLOAD GCB00intraocular lens12 reports
- SMARTLOAD GCB00intraocular lens11 reports
- SMARTLOAD GCB00intraocular lens10 reports
- SMARTLOAD GCB00intraocular lens8 reports
- SMARTLOAD GCB00intraocular lens7 reports
- SMARTLOAD GAB00intraocular lens6 reports
- SMARTLOAD GAB00intraocular lens6 reports
- SMARTLOAD GCB00intraocular lens5 reports
- SMARTLOAD GCB00intraocular lens5 reports
- SMARTLOAD GCB00intraocular lens5 reports
- SMARTLOAD GAB00intraocular lens5 reports
- SMARTLOAD GAB00intraocular lens5 reports
- SMARTLOAD GCB00intraocular lens4 reports
- SMARTLOAD GCB00intraocular lens4 reports
- SMARTLOAD GCB00intraocular lens4 reports
- SMARTLOAD GCB00intraocular lens4 reports
- SMARTLOAD GCB00intraocular lens4 reports
- SMARTLOAD GAB00intraocular lens4 reports
- SMARTLOAD GAB00intraocular lens4 reports
- SMARTLOAD GAB00intraocular lens4 reports
- SMARTLOAD GCB00intraocular lens3 reports
- SMARTLOAD GCB00intraocular lens3 reports
- SMARTLOAD GCB00intraocular lens3 reports
- SMARTLOAD GAB00intraocular lens3 reports
- SMARTLOAD GAB00intraocular lens3 reports
- SMARTLOAD GAB00intraocular lens3 reports
- SMARTLOAD GAB00intraocular lens3 reports
- SMARTLOAD GCB00intraocular lens2 reports
- SMARTLOAD GCB00intraocular lens2 reports
- SMARTLOAD GCB00intraocular lens2 reports
- SMARTLOAD GCB00intraocular lens2 reports
- SMARTLOAD GAB00intraocular lens2 reports
- SMARTLOAD GAB00intraocular lens2 reports
- SMARTLOAD GAB00intraocular lens2 reports
- SMARTLOAD GAB00intraocular lens2 reports
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GCB00intraocular lens1 report
- SMARTLOAD GAB00intraocular lens1 report
- SMARTLOAD GAB00intraocular lens1 report
- SMARTLOAD GAB00intraocular lens1 report
- SMARTLOAD GAB00intraocular lens1 report
- SMARTLOAD GIB00intraocular lens1 report
- SMARTLOAD GIB00intraocular lens1 report
Recent SMARTLOAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862464 ↗MalfunctionSep 17, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797052 ↗MalfunctionAug 18, 2026Break; Device Difficult to Setup or Prepare; Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311643 ↗MalfunctionJul 28, 2026Contamination
It was reported that there was a piece of plastic sat on the Intraocular Lens (IOL) and entered the patient's eye with it. The piece of plastic was removed and it was intact. There was apparently nothing wrong with the IOL. Through follow-up, we learned, that the patient is fine and no additional treatment was required. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063486 ↗MalfunctionJul 16, 2026Device Difficult to Setup or Prepare; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25843651 ↗MalfunctionJul 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25843174 ↗MalfunctionJul 16, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25842814 ↗MalfunctionJul 15, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834168 ↗MalfunctionJun 16, 2026Material Fragmentation
IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), IT RELEASED DEBRIS INTO THE CAPSULAR BAG. NO IMPACT ON THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524406 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB MODEL INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, TUBING SETS, AND DK9000 AS THEY WERE USED ON EACH PATIENT. AS THE DK9000 IS A DEVICE THE CLINIC STERILIZES THEMSELVES, THIS IS LISTED AS A CONCOMITANT DEVICE AND NOT BEING REPORTED AGAINST. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL
Patient problems: Endophthalmitis
MAUDE report 25452007 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB MODEL INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, TUBING SETS, AND DK9000 AS THEY WERE USED ON EACH PATIENT. AS THE DK9000 IS A DEVICE THE CLINIC STERILIZES THEMSELVES, THIS IS LISTED AS A CONCOMITANT DEVICE AND NOT BEING REPORTED AGAINST. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL
Patient problems: Endophthalmitis
MAUDE report 25452004 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB MODEL INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, TUBING SETS, AND DK9000 AS THEY WERE USED ON EACH PATIENT. AS THE DK9000 IS A DEVICE THE CLINIC STERILIZES THEMSELVES, THIS IS LISTED AS A CONCOMITANT DEVICE AND NOT BEING REPORTED AGAINST. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL
Patient problems: Endophthalmitis
MAUDE report 25451968 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SITE HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO JOHNSON AND JOHNSON LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP, WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS, AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB MODEL INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, TUBING SETS, AND DK9000 AS THEY WERE USED ON EACH PATIENT. AS THE DK9000 IS A DEVICE THE CLINIC STERILIZES THEMSELVES, THIS IS LISTED AS A CONCOMITANT DEVICE AND NOT BEING REPORTED AGAINST. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL
Patient problems: Endophthalmitis
MAUDE report 25451880 ↗MalfunctionJun 5, 2026Break; Mechanical Jam
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) COULD NOT BE SQUEEZED OUT OF THE CARTRIDGE AS IT APPEARED CROOKED OR STUCK. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE ISSUE WAS DISCOVERED DURING PREPARATION PRIOR TO USE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410876 ↗MalfunctionMay 21, 2026Contamination
IT WAS REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A FOREIGN BODY WAS OBSERVED INSIDE THE PATIENT¿S EYE. THE FOREIGN BODY WAS FOUND TO HAVE ORIGINATED FROM THE DEVICE USED TO IMPLANT THE IOL. THE FOREIGN BODY WAS REMOVED FROM THE EYE, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED, AND THERE WAS NO DELAY IN THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249448 ↗
Other Johnson & Johnson Surgical Vision, Inc. products
- TECNIS IOL1,344 models · 10,702 reports · 3 recalls
- FS DISPOSABLE INTERFACE2 models · 4,239 reports
- TECNIS SIMPLICITY112 models · 2,730 reports · 1 recall
- SENSAR IOL112 models · 1,213 reports
- TECNIS CL IOL42 models · 558 reports
- TECNIS ODYSSEY IOL49 models · 389 reports
- TECNIS ODYSSEY TORIC II IOL106 models · 285 reports
- UNFOLDER EMERALD2 models · 258 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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