Devices › General surgery tray
Device brand name · General surgery tray kit
CUSTOM-PAK Surgical Procedure Pack: medical device reports filed with FDA
649 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Houston. Product code LRO.
- 649
- device reports naming the brand
- 0% of all MAUDE reports · about 57 a year
- 34
- reports, 12 months to August 2026
- 45 in the 12 months before
- 59.2%
- classified as malfunction
- 92.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
649 medical device reports received by FDA name the brand "CUSTOM-PAK Surgical Procedure Pack" (general surgery tray kit); the manufacturer given most often on reports is Alcon Research - Houston; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
34 reports arrived in the 12 months to August 2026, down 24% from 45 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (59.2%) and injury (40.8%); across all general surgery tray reports (product code LRO) death is recorded in 0% and malfunction in 92.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are dull, blunt (15.7%), insufficient device problem information (7.6%) and device operates differently than expected (5.7%). The patient problems coded most often are inflammation, foreign body in patient and endophthalmitis. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 21,411 reports carrying product code LRO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Dull, blunt | 102 | 15.7% | 1.4% |
| Insufficient device problem information | 49 | 7.6% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 37 | 5.7% | 0.5% |
| Product quality problem | 37 | 5.7% | 0.6% |
| Device contamination with chemical or other material | 29 | 4.5% | 1% |
| Obstruction of flow | 28 | 4.3% | 2.6% |
| Complete blockage | 27 | 4.2% | 1.4% |
| Particulates | 23 | 3.5% | 0.4% |
| Contamination | 21 | 3.2% | 0.9% |
| Detachment of device or device componentpart of the device came off | 18 | 2.8% | 1% |
| Detachment of device component | 15 | 2.3% | 0.4% |
| Defective component | 9 | 1.4% | 0.3% |
| Loose or intermittent connection | 8 | 1.2% | 0.6% |
| Material integrity problema problem with the device material | 8 | 1.2% | 0.6% |
| Sharp edges | 8 | 1.2% | 0.1% |
| Breakthe device broke | 7 | 1.1% | 4.5% |
| Material fragmentation | 7 | 1.1% | 0.5% |
| Material twisted/bent | 7 | 1.1% | 2.3% |
| Contamination /decontamination problem | 6 | 0.9% | 1.1% |
| Disconnection | 6 | 0.9% | 0.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Inflammationinflammation | 46 | 7.1% |
| Foreign body in patientpart of a device left in the patient | 45 | 6.9% |
| Endophthalmitisinfection inside the eye | 41 | 6.3% |
| Toxic anterior segment syndrome (tass) | 31 | 4.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 19 | 2.9% |
| Blurred vision | 17 | 2.6% |
| Hypopyon | 17 | 2.6% |
| Capsular bag tear | 16 | 2.5% |
| Corneal edema | 15 | 2.3% |
| Toxicity | 15 | 2.3% |
| Conjunctivitispink eye | 14 | 2.2% |
| Eye paineye pain | 13 | 2% |
| Device embedded in tissue or plaque | 11 | 1.7% |
| Uveitis | 11 | 1.7% |
| Abrasion | 9 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CUSTOM-PAK Surgical Procedure Pack | Product code LRO | All MAUDE reports |
|---|---|---|---|
| Reports | 649 | 21,411 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 40.8% | 7.2% | 36.2% |
| Classified as malfunction | 59.2% | 92.1% | 62.3% |
| Filed by the manufacturer | 100% | 95.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LRO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CONSTELLATION Surgical Procedure Pack | 10,652 | 5,185 | 0% |
| CONSTELLATION Surgical Procedure Pak | 3,180 | 134 | 0% |
| CENTURION Surgical Procedure Pak | 3,018 | 929 | 0% |
| Infiniti Surgical Procedure Pak | 223 | 1 | 0% |
| UNITY TOTAL PLUS Combined Procedure Pack | 212 | 199 | 0% |
| CENTURION ULTRAVIT Probe Procedure Pak | 180 | 52 | 0% |
| Deroyal | 587 | 14 | 0.7% |
| Medline Industries, Inc. | 429 | 100 | 0.2% |
| Cardinal Health | 589 | 185 | 0.2% |
| Custom Pak | 1,262 | 0 | 0% |
| Halyard | 156 | 11 | 1.3% |
| CONSTELLATION ULTRAVIT Probe | 734 | 196 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about CUSTOM-PAK Surgical Procedure Pack reports
How many FDA reports name CUSTOM-PAK Surgical Procedure Pack?
649 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 34 in the latest 12 months.
What kinds of events are reported?
malfunction (59.2%) and injury (40.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
dull, blunt (15.7%), insufficient device problem information (7.6%), device operates differently than expected (5.7%), product quality problem (5.7%) and device contamination with chemical or other material (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CUSTOM-PAK Surgical Procedure Pack was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.