86-11
Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination
7 firms from 3 countries are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 17 October 2013, the newest to 29 November 2016.
- 7firms listed
- 3countries
- 5 March 2026alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
Note: The revision of this Import Alert (IA) dated 09/01/2021 updates the guidance, agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***). FDA has collected and analyzed samples of contact lenses (corrective and non-corrective (plano)) with potentially hazardous microbial contamination that may pose a health risk. Firms who have produced contact lenses with sterility and quality issues can create a potential health risk.
Quoted from the “Reason for Alert” section of the FDA page for 86-11, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 86-11
| Firm | Country | Listed since | |
|---|---|---|---|
| Aspiration IntlUnit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR | Hong Kong Sar | 9 Jun 201511 yr | |
| Con Tech Korea Co. Ltd.Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF) | Korea (the Republic of) | 16 Jun 201412 yr | |
| Contech Korea970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF) | Korea (the Republic of) | 16 Jun 201412 yr | |
| MAX LOOK CONTACT LENS / KIM105 Hyeopseok-Ri , Namcheon-Myeon , Gyeongsan, Gyeongsangbugdo KOREA (THE REPUBLIC OF) | Korea (the Republic of) | 17 Oct 201312 yr | |
| C WORLD KSG CORPORATIONNO 2 8th Street Golden Mile Business Par , Cavite, Calabarzon PHILIPPINES | Philippines | 19 Nov 201510 yr | |
| RICHARD KIMThe Levels Com , Cavite, Calabarzon PHILIPPINES | Philippines | 29 Nov 20169 yr | |
| Richard KimUnit 1206 , The Levels Anaheim Condo , Filinvest City, Muntinlupa City, PHILIPPINES | Philippines | 29 Nov 20169 yr |