Model Number PCB00 |
Device Problems
Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Initial reporter telephone number: (b)(6).Device manufacture date: unknown, as serial number was not provided.Device evaluation: product testing could not be performed because the device was not returned for evaluation.None of the packaging was saved for return.The complaint cannot be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the serial number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that the theatre staff feels that the internal sterilized wrapping is not sealed firmly enough and could risk the intraocular lens (iol) becoming contaminated.The team's brief description of the event indicated the sterile sealant on the lens packaging is very fragile and it takes a far less effort to open than expected.They have concerns that the contents could easily become desterilized.The customer did not save the packaging for return.No device serial number was provided.No further information was provided.
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Manufacturer Narrative
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Corrected information: upon further review of the file it was determined that this event is no longer reportable.The customer was dissatisfied about the seal and beliefs that it could risk the lens becoming decontaminated.However, no actual report of an unsterile product was received.Therefore, this supplemental filing is to state that this event is not reportable per additional review of the information received and no further information will be provided.Medical device problem code: 3191 - dissatisfaction with the design was added.Medical device problem code: 1421 - delivered as unsterile product was removed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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