No other complaints were reported for this lot.All batches are released according to the required specifications and all initial testing results are within specification (ph and osmo are within specifications).A complaint sample, one carton with insert and unopened sterile package with viscoat and provisc syringes, were received.The lab has retested the complaint sample: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform).In addition, the lab has retested the reference sample of this batch: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform).As the complaint sample and retain sample was conforming and all initial testing results are within specification, a conclusive root cause could not be determined for the inflammation.The manufacturer internal reference number is: (b)(4).
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