LAMINARRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LAMINAR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 203
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 13 models of LAMINAR by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2018 and Sep 25, 2026 — classified as 8 injuries, 195 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (173 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
LAMINAR recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 14, 2024Open, Classified
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
Z-1755-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported LAMINAR problems
Device problems
- Nonstandard Device173
- Appropriate Device Problem Term/Code Not Available18
- Complete Blockage11
- Contamination9
- Obstruction of Flow5
- Adverse Event Without Identified Device or Use Problem2
- Accessory Incompatible1
- Failure to Prime1
Patient problems
- No Clinical Signs, Symptoms or Conditions185
- No Patient Involvement5
- Eye Burn3
- No Code Available3
- Eye Injury2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
LAMINAR models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LAMINAR OPOHF21LUnit, phacofragmentation1 recall175 reports
- LAMINAR OPOCR3021LUnit, phacofragmentation6 reports
- LAMINAR OPOCR3020RUnit, phacofragmentation5 reports
- LAMINAR OPOR3020LUnit, phacofragmentation4 reports
- LAMINAR OPOCR3021RUnit, phacofragmentation3 reports
- LAMINAR OPOS20LUnit, phacofragmentation2 reports
- LAMINAR OPOHF20LUnit, phacofragmentation2 reports
- LAMINAR OPOCR3020LUnit, phacofragmentation1 report
- LAMINAR OPOR0020LUnit, phacofragmentation1 report
- LAMINAR OPOR3021GUnit, phacofragmentation1 report
- LAMINAR OPOS21LDUnit, phacofragmentation1 report
- LAMINAR OPOR3021RUnit, phacofragmentation1 report
- LAMINAR OPOF3020RUnit, phacofragmentation1 report
Recent LAMINAR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Contamination
Patient problems: Eye Injury
MAUDE report 50903485 ↗MalfunctionSep 25, 2026Contamination
Patient problems: Eye Injury
MAUDE report 50903465 ↗InjuryAug 11, 2026Contamination
It was reported that metal particles were found in the patient's eye during a medical examination following surgery. Through follow-up, we learned, that an anterior chamber lavage was performed on (b)(6) 2026. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210968 ↗MalfunctionAug 3, 2026Contamination
It was reported that, while using the device during the procedure, metal particles were found on the patient's anterior capsule during the groove removal. The particles were removed and the procedure was successfully completed. There was no patient injury and no further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123607 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON NOVEMBER 17, 2025 A SALES REP WAS PRESENT IN THE OPERATING ROOM AND INDICATED THAT THE SURGEON COULD NOT DETERMINE WHEN THE CAPSULE BAG RUPTURE OCCURRED; WHETHER DURING POLISHING OR DURING IRRIGATION/ASPIRATION. THE ISSUE WAS FIRST RECOGNIZED WHEN THE SURGEON SAW VITREOUS DURING IMPLANTATION OF A DCB00 LENS. THE SURGEON SAW THE LENS DROP TO THE BOTTOM OF THE EYE AND HAD TO FISH THE LENS OUT. A VITRECTOMY AND SUTURE WAS NECESSARY AND THE PATIENT WAS SENT TO ANOTHER SITE TO REPLACE THE INTRAOCULAR LENS (IOL). THE EVENT CAUSED AN APPROXIMATELY 20 MINUTE DELAY IN THE PROCEDURE. THE AFFECTED EYE WAS THE LEFT EYE. THE PATIENT¿S CONDITION AND RECOVERY STATUS ARE CURRENTLY UNKNOWN. SALES REP NOTED THAT THE SURGEON IS RECENTLY GRADUATED AND BELIEVES THE EVENT WAS NOT RELATED TO THE PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NOTE: THIS REPORT IS FOR THE SLEEVE. A SEPARATE REPORT WILL FILED AGAINST THE I/A HANDPIECE AND IOL.
Patient problems: Capsular Bag Tear
MAUDE report 23772934 ↗MalfunctionApr 25, 2025Contamination; Contamination
A CUSTOMER REPORTED A HARD PLASTIC SHREDS COMING FROM THE YELLOW PHACO/IRRIGATION ASPIRATION SLEEVE, LAMINAR FLOW PHACO TIP. THE THE PLASTIC SHRED ENTERED A PATIENT'S EYE, WHICH WAS REMOVED WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT, AND THE SURGERY CONCLUDED UNEVENTFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21911600 ↗MalfunctionAug 6, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN (B)(6) 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921265 ↗MalfunctionAug 6, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921085 ↗MalfunctionAug 6, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19921016 ↗MalfunctionAug 6, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19920988 ↗MalfunctionAug 6, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19920960 ↗MalfunctionMay 13, 2024Contamination; Contamination
IT WAS REPORTED THAT SOME METAL BITS WAS FLAKING OFF FROM THE PHACO TIP DURING PHACO SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19305853 ↗MalfunctionApr 1, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT ACCOUNT RECEIVED A BOX OF OPOHF21L WITH ONLY 1 IRRIGATION HOLE. THERE IS NO PATIENT ADVERSE EVENT TO REPORT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011159 ↗MalfunctionApr 1, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT ACCOUNT RECEIVED A BOX OF OPOHF21L WITH ONLY 1 IRRIGATION HOLE. THERE IS NO PATIENT ADVERSE EVENT TO REPORT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009674 ↗MalfunctionApr 1, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT ACCOUNT RECEIVED A BOX OF OPOHF21L WITH ONLY 1 IRRIGATION HOLE. THERE IS NO PATIENT ADVERSE EVENT TO REPORT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009648 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page