LAMINAR OPOHF21LRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SLEEVE & TEST CHAMBER, 21GA HIGH FLOW · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Laminar high flow sleeve for eye surgery has 175 adverse event reports, with no deaths and 2 injuries. The reports mostly describe nonstandard sleeves, with some boxes containing sleeves that have only one irrigation hole. One recall is open, started in March 2024, over sleeves that may be missing a port hole, which can reduce the flow that cools the surgical tip.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 05050474573376), received between Jan 8, 2018 and Apr 1, 2024 — classified as 2 injuries, 173 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (173 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Nonstandard Device173
- Appropriate Device Problem Term/Code Not Available18
- Accessory Incompatible1
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions172
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
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 ↗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 19009647 ↗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 19009632 ↗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 19009629 ↗MalfunctionMar 31, 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 19009620 ↗MalfunctionMar 31, 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 19009616 ↗MalfunctionMar 31, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT ACCOUNT RECEIVED A BOX OF OPOHF21L WITH ONLY 1 IRRIGATION HOLE. ADDITIONAL INFORMATION WAS RECIEVED AND IT WAS LEARNT THAT AT LEAST ONE PATIENT HAD SHALLOWING OF ANTERIOR CHAMBER. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19009610 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 33 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004968 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 62 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001841 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 61 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001825 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 60 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001821 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 59 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001809 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 58 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001804 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 57 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001794 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 56 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001789 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 55 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001775 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 54 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001768 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 53 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001750 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 52 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001736 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 51 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001732 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 50 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001718 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 49 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001709 ↗MalfunctionMar 29, 2024Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT CUSTOMER HAD OPOHF21L SLEEVES THAT HAVE 1 IRRIGATION PORT ONLY. APPLICATION SUPPORT SPECIALIST WAS AT THE ACCOUNT AND CONFIRMED THE SLEEVES ON HAND HAVE HAD THE SAME ISSUE WITH 62 SLEEVES AFFECTED (8 BOXES, 14 SINGLES) OF LOT 60479361. THERE WAS NO PATIENT OR CASE IMPACT. THE SLEEVE ISSUE WAS CAUGHT DURING SET UP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 48 OF 62. SEPARATE REPORTS WILL BE SUBMITTED FOR REST OF THE QUANTITIES INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001702 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.