Devices › Lenses, soft contact, extended wear
Device brand name · Extended wear soft contact lens
Focus Night & Day: medical device reports filed with FDA
215 reports name it, 2002–2009. Manufacturer given most often on reports: P T Ciba Vision Batam. Product code LPM.
- 215
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.5%
- classified as malfunction
- 1.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 215 reports that name the brand "Focus Night & Day" (extended wear soft contact lens), received between January 2002 and September 2009; the manufacturer given most often on reports is P T Ciba Vision Batam. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 injury (99.5%) and malfunction (0.5%); across all lenses, soft contact, extended wear reports (product code LPM) death is recorded in 0% and malfunction in 1.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are reaction (6.5%), device, removal of (non-implant) (2.8%) and microbial contamination of device (1.9%). The patient problems coded most often are corneal ulcer, treatment with medication(s) and pain. 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
No report naming Focus Night & Day was received in the five years to August 2026; the latest was received in September 2009.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,076 reports carrying product code LPM. 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 |
|---|---|---|---|
| Reactiona reaction, type not specified | 14 | 6.5% | 1.1% |
| Device, removal of (non-implant) | 6 | 2.8% | 0.4% |
| Microbial contamination of device | 4 | 1.9% | 0.4% |
| Replace | 4 | 1.9% | 0.7% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 0.9% | 0.3% |
| Device remains implanted | 1 | 0.5% | 0.1% |
| Explanted | 1 | 0.5% | 0% |
| Foreign material | 1 | 0.5% | 0.1% |
| Lens (iol), torn, split, cracked | 1 | 0.5% | 0% |
| Lens replacement | 1 | 0.5% | 0.1% |
| Off-label use | 1 | 0.5% | 0.2% |
| Particulates | 1 | 0.5% | 0% |
| Source, detachment from | 1 | 0.5% | 0% |
| Sticking | 1 | 0.5% | 0.3% |
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 |
|---|---|---|
| Corneal ulcer | 150 | 69.8% |
| Treatment with medication(s) | 121 | 56.3% |
| Painpain, site not specified | 107 | 49.8% |
| Red eye(s) | 39 | 18.1% |
| Therapy/non-surgical treatment, additional | 35 | 16.3% |
| Visual impairmentreduced vision | 29 | 13.5% |
| Discharge | 28 | 13% |
| Corneal scar | 26 | 12.1% |
| Discomfortdiscomfort | 23 | 10.7% |
| Iritis | 21 | 9.8% |
| Keratitis | 21 | 9.8% |
| Bacterial infectiona bacterial infection | 20 | 9.3% |
| Other (for use when an appropriate patient code cannot be identified) | 19 | 8.8% |
| Corneal infiltrates | 16 | 7.4% |
| Hospitalization required | 15 | 7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Focus Night & Day | Product code LPM | All MAUDE reports |
|---|---|---|---|
| Reports | 215 | 3,076 | 26,136,888 |
| Share of that pool | — | 7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 99.5% | 96.3% | 36.2% |
| Classified as malfunction | 0.5% | 1.4% | 62.3% |
| Filed by the manufacturer | 99.5% | 91.7% | 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 LPM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Acuvue Oasys | 719 | 27 | 0% |
| ACUVUE OASYS for ASTIGMATISM | 261 | 18 | 0% |
| Biofinity Sphere (comfilcon A) | 226 | 21 | 0% |
| Biofinity Toric (comfilcon A) | 212 | 16 | 0% |
| Acuvue 2 | 174 | 5 | 0% |
| Air Optix Night & Day Aqua | 151 | 9 | 0% |
| Renu With Moistureloc Multi-Purpose Solution | 387 | 0 | 0% |
| Avaira Sphere Enfilcon A | 158 | 0 | 0% |
| Renu Multiplus Multi-Purpose Solution | 161 | 0 | 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 Focus Night & Day reports
How many FDA reports name Focus Night & Day?
215 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (99.5%) and malfunction (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
reaction (6.5%), device, removal of (non-implant) (2.8%), microbial contamination of device (1.9%), replace (1.9%) and difficult to remove (0.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Focus Night & Day 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.