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        "reason": "One lot manufactured with an invalid sterilization cycle."
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      {
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        "reason": "Lens blisters may have an incomplete or leaking seal which may render them unsterile."
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      {
        "resNumber": "Z-2166-2025",
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    {
      "code": "FXP",
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    {
      "code": "GEA",
      "deviceName": "Cannula, Surgical, General & Plastic Surgery",
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    {
      "code": "GEX",
      "deviceName": "Powered Laser Surgical Instrument",
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    {
      "code": "HKP",
      "deviceName": "Instrument, Vitreous Aspiration And Cutting, Battery-Powered",
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    {
      "code": "HMF",
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    {
      "code": "HMT",
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    {
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    {
      "code": "HOO",
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}
