COMPACT INTUITIV OPO80Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · PHACO PACK, APOLLO COMPACT, SINGLE USE · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Johnson & Johnson single-use phaco pack is used in cataract surgery to break up and remove the cloudy lens. Most of the 74 reports describe unsealed packaging or holes in the lid, with surgery centers concerned the tubing set was no longer sterile; a few mention suction problems, and one describes increased eye pressure. There are no deaths and 1 injury. One recall, open since December 2022, concerns a gap between the housing and pack cover that could affect priming and vacuum during surgery.

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: 74
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 05050474573352), received between Aug 2, 2018 and May 19, 2020 — classified as 1 injury, 73 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (70 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.

Recalls naming this device

Dec 7, 2022Open, Classified
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Z-1007-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Unsealed Device Packaging70
Suction Problem4

Patient problems

No Patient Involvement70
No Consequences Or Impact To Patient3
Intraocular Pressure Increased1

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 5 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073262 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 3 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073256 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 4 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073245 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 2 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073237 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 1 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073231 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUITIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 3 OF 3 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073226 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUITIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 2 OF 3 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073224 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUITIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 1 OF 3 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073222 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE.
Patient problems: No Patient Involvement
MAUDE report 10073202 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE.
Patient problems: No Patient Involvement
MAUDE report 10073186 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 5 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073180 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 4 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073171 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 3 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073160 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 2 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073145 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 1 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073137 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 5 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073124 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 4 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073107 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 3 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073084 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 2 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073077 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 1 OF 5 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073061 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 4 OF 4 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073024 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 3 OF 4 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10073013 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 2 OF 4 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10072992 ↗
MalfunctionMay 19, 2020Unsealed Device Packaging; Unsealed Device Packaging
A SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. THIS IS 1 OF 4 REPORTS.
Patient problems: No Patient Involvement
MAUDE report 10072972 ↗
MalfunctionMar 16, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE SURGERY CENTER REPORTED OBSERVING HOLES WORN INTO THE TYVEK LID OF A COMPACT INTUTIV PACK DISPOSABLE TUBING SET MODEL OPO80. THE SURGERY CENTER HAD CONCERNS THE PACKAGING HAD BEEN COMPRISED AND THE TUBING PACK WAS NO LONGER STERILE. A VISUAL INSPECTION CONFIRMED A PUNCTURE HOLE ON THE TYVEK LID.
Patient problems: No Patient Involvement
MAUDE report 9835139 ↗

Device details

UDI-DI	`05050474573352`
Brand	COMPACT INTUITIV
Model	OPO80
Company	Johnson & Johnson Surgical Vision, Inc.
Product code	HQC · Unit, phacofragmentation
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 8, 2022

Device type (GMDN): Surgical irrigation/aspiration tubing set

A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.