Z-0991-2018Class II

ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54

Name: Z-0991-2018 ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54
Creator: Alden Optical
Published: 2017-11-03
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Alden Optical began a recall of ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of... on 2017-11-03. FDA classified it as Class II and gives the reason as "Contact lenses lack sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0991-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2018-03-13
Terminated: 2018-06-19
Recalling firm: Bausch & Lomb Incorporated
Product: ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Contact lenses lack sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Quantity in commerce: 4
Distribution: Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.
Product codes and lots: AZ128410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0982-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0983-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0984-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0985-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0986-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0987-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0988-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0989-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0990-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0991-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code LPL

K052703Class IIAlden Classic (Polymacon) Multifocal (Spherical and Toric), Alden Classic 55 (Methafilcon a) Multifocal (SphericalAlden Optical Labs., Inc. / cleared 2005-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)