Catalog Number UNKNOWN |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Inflammation (1932); Pain (1994); Loss of Vision (2139); Reaction, Injection Site (2442)
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Event Date 01/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the patient received an eylea injection with the unspecified bd¿ syringe in the right eye, but began experiencing "progressively worsening problems" later that evening, including watering, pain, and loss of vision in the injected eye.There was "continuing pain" and "complete loss of vision" in the right eye the following morning, which symptoms have reportedly "continued to this day".After an investigation, certain lots of eylea kits included unspecified bd¿ syringes that were lubricated with silicone, which was found to be the cause of "intraocular inflammation" and other adverse reactions in patients who received injections.The following information was provided by the initial reporter: my client received an eylea injection in his right eye at on (b)(6) 2018 - 4mg, lot# 8148200093, expiration date july 31, 2018.So far as we are aware, there were no complications or irregularities in the procedure itself.As instructed, the physician used the syringe provided and packaged with the eylea dosage.My client was to follow-up in four weeks.In the evening on (b)(6), my client began to experience progressively worsening problems, including watering and pain and loss of vision in the right eye.He woke the following morning with continuing pain and complete loss of vision in the eye that had been injected.This was the beginning of severe problems (including loss/deterioration of vision) that have continued to this day, as a result of the subject eylea injections.In this same time frame coinciding with my client's problems, there was a significantly increased incidence of intraocular inflammation (ioi) and associated issues following eylea injections (an incidence will above the expected incidence and well above the level risk as disclosed to the public, patients, and physicians).An investigation was conducted and determined that certain lots of eylea kits - including lot number 8148200093 - included syringes that were lubricated with silicone; and this was the cause and origin of the high incidence of adverse reactions and problems in patient receiving injections.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Event Description
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It was reported that the patient received an eylea injection with the unspecified bd¿ syringe in the right eye, but began experiencing "progressively worsening problems" later that evening, including watering, pain, and loss of vision in the injected eye.There was "continuing pain" and "complete loss of vision" in the right eye the following morning, which symptoms have reportedly "continued to this day".After an investigation, certain lots of eylea kits included unspecified bd¿ syringes that were lubricated with silicone, which was found to be the cause of "intraocular inflammation" and other adverse reactions in patients who received injections.The following information was provided by the initial reporter: my client received an eylea injection in his right eye at on (b)(6) 2018 - 4mg, lot# 8148200093, expiration date july 31, 2018.So far as we are aware, there were no complications or irregularities in the procedure itself.As instructed, the physician used the syringe provided and packaged with the eylea dosage.My client was to follow-up in four weeks.In the evening on (b)(6), my client began to experience progressively worsening problems, including watering and pain and loss of vision in the right eye.He woke the following morning with continuing pain and complete loss of vision in the eye that had been injected.This was the beginning of severe problems (including loss/deterioration of vision) that have continued to this day, as a result of the subject eylea injections.In this same time frame coinciding with my client's problems, there was a significantly increased incidence of intraocular inflammation (ioi) and associated issues following eylea injections (an incidence will above the expected incidence and well above the level risk as disclosed to the public, patients, and physicians).An investigation was conducted and determined that certain lots of eylea kits - including lot number 8148200093 - included syringes that were lubricated with silicone; and this was the cause and origin of the high incidence of adverse reactions and problems in patient receiving injections.
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Search Alerts/Recalls
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