CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Cornea Coat, Hydroxypropylmethylcellulose Syringe recalled
Insight Instruments is recalling Cornea Coat, Hydroxypropylmethylcellulose Syringe, distributed nationwide in the US. The recall was initiated on 24 Apr 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1056-2014
- FDA event ID
- 65107
- Recalling firm
- Insight Instruments, Stuart, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Apr 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +282 days |
| 12 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA.
Product as listed by the FDA
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Cornea Coat, Hydroxypropylmethylcellulose Syringe recalled?
Yes. Insight Instruments recalled Cornea Coat, Hydroxypropylmethylcellulose Syringe on 24 Apr 2013. The recall is Class II and its status is Terminated. Recall number D-1056-2014.
Why was it recalled?
Marketed without an Approved NDA/ANDA.
Which lots are affected?
Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Insight Instruments
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MLS Torpedo Mini-Light Ophthalmic single-port illumination recalled | Insight Instruments | Other | Nationwide |
| Device | CLASS II | MIS ( Multi-Port Illumination System) Illuminated pilot recalled | Insight Instruments | Other | IL |