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Lot Number 10068 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
Unspecified Infection (1930)
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Event Type
malfunction
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Event Description
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An initial spontaneous report from the united states was received via non-med originating from a consumer on 19-may-2021 who was the wife of a male patient of unknown age who experienced eye infection, poor quality product administered, and product contamination physical following the administration of us refresh contacts 510(k) (carmellose sodium) for "unknown indication".Allergan received the report on 25-may-2021.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: 10068 (expiry date: 25-nov-2022).On an unknown date in (b)(6) 2021, the patient experienced "eye infection" (eye infection).On an unknown date, the patient experienced "kind of slimy residue in it / black slimy stuff in it / black slimy material" (product contamination physical;poor quality product administered).This case was considered non-serious.Patient reported on "nothing would squirt out of bottle due to black slime.There was some kind of slimy residue in it.This needed to be resolved immediately.Reporter confirmed that product at first would not dispense, then they noticed black slimy stuff in it, when they opened the bottle up, it appeared to be filled with black slimy material.Product purchased about a month ago.Between uses, product was stored on dresser.No signs to damage to packaging when received.Reporter stated that a few days ago, her husband experienced an eye infection.Laboratory tests were not reported.Action taken with the suspect drug us refresh contacts 510(k) was unknown.Treatment information was not provided.At the time of the report, the outcome of eye infection was reported as unknown.
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Event Description
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A follow-up spontaneous report (regulatory no: (b)(4)) from the united states was received via non-med originating from a consumer on 08-jul-2021 who was the wife of a male patient of unknown age who experienced eye infection, poor quality product administered, and product contamination physical following the administration of us refresh contacts 510(k) (carmellose sodium) for "unknown indication".Allergan received the report on 08-jul-2021.Medical history was not reported.Concomitant medications were not reported.No dosage information was reported for us refresh contacts 510(k) (carmellose sodium) (eye drops, solution).The lot number was reported as: 10068 (expiry date: 25-nov-2022).On an unknown date in (b)(6) 2021, the patient experienced "eye infection" (eye infection).On an unknown date, the patient experienced "kind of slimy residue in it / black slimy stuff in it / black slimy material" (product contamination physical;poor quality product administered).This case was considered non-serious.Patient reported on "nothing would squirt out of bottle due to black slime.There was some kind of slimy residue in it.This needed to be resolved immediately.Reporter confirmed that product at first would not dispense, then they noticed black slimy stuff in it, when they opened the bottle up, it appeared to be filled with black slimy material.Product purchased about a month ago.Between uses, product was stored on dresser.No signs to damage to packaging when received.Reporter stated that a few days ago, her husband experienced an eye infection.Laboratory tests were not reported.Action taken with the suspect drug us refresh contacts 510(k) was unknown.Treatment information was not provided.At the time of the report, the outcome of eye infection was reported as unknown.Tracking of changes: 19-may-2021: initial source documents received.08-jul-2021: additional information received: evaluation codes were added, narrative was updated accordingly.Site of manufacture quality investigation results received.
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