# China NMPA Product Recall - Central aperture posterior chamber refractive intraocular lens

Source: https://www.globalkeysolutions.net/records/china_product_recall/staar-surgical-ag-switzerland/d7fee09a-481c-4c0c-bb9c-1263afebdbd1/
Source feed: China

> China NMPA product recall for Central aperture posterior chamber refractive intraocular lens by STAAR Surgical AG, Switzerland published December 28, 2023. Recall level: Level 2 Recall. STAAR Surgical AG, Switzerland, through its local entity STAAR Surgical (Shanghai) Co., Ltd., has an

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: STAAR Surgical AG of Switzerland is voluntarily recalling its posterior chamber refractive intraocular lenses with central aperture.
- Company Name: STAAR Surgical AG, Switzerland
- Publication Date: 2023-12-28
- Product Name: Central aperture posterior chamber refractive intraocular lens
- Recall Level: Level 2 Recall
- Recall Reason: The measured value of MTF (modulation transfer function) is lower than its minimum limit, resulting in a deviation in refractive power.
- Discovering Company: Dashi Eye Care Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: STAAR Surgical AG, Switzerland
- Summary: STAAR Surgical AG, Switzerland, through its local entity STAAR Surgical (Shanghai) Co., Ltd., has announced a voluntary Class II recall concerning its Central Foramen Posterior Chamber Refractive Intraocular Lenses, known commercially as the COLLAMER IMPLANTABLE CONTACT LENS (National Medical Device Registration Certificate No. 20143165000). This recall, publicly reported by the National Medical Products Administration (NMPA) on December 28, 2023, stems from a critical quality issue. The core problem identified is a refractive error, specifically that the measured modulation transfer function (MTF) value of the lenses was found to be below its predetermined minimum acceptable limit. The MTF is a crucial metric for evaluating the optical quality and image clarity of a lens, and its deficiency can directly affect visual outcomes for patients. As a Class II recall, this indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company has initiated this action to uphold product efficacy and patient safety standards under the regulatory oversight of the NMPA. Comprehensive details regarding the specific affected product batches, specifications, and required actions are outlined in the official "Medical Device Recall Event Report Form".

Company: https://www.globalkeysolutions.net/companies/staar-surgical-ag-switzerland/0ecd9eba-1992-42bb-8d3d-d3398bbddaba/