NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS
FDA premarket approval P010019/S002 · decided 2003-03-19
Approval details
- PMA number
- P010019
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2003-02-24
- Decision date
- 2003-03-19
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE FOLLOWING INDICATION: NIGHT & DAY SOFT CONTACT LENSES ARE ALSO INDICATED FOR THERAPEUTIC USE. USE AS A BANDAGE TO PROTECT THE CORNEA AND TO RELIEVE CORNEAL PAIN DURING THE TREATMENT OF ACUTE OR CHRONIC OCULAR PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL EROSIONS, ENTROPION, CORNEAL EDEMA, AND CORNEAL DYSTROPHIES AS WELL AS POST-SURGICAL CONDITIONS RESULTING FROM CATARACT EXTRACTION AND CORNEAL SURGERY. NIGHT & DAY SOFT CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE OPTI
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510(k) clearances by this applicant
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| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |