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Model Number ZCT300 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Therapeutic Effects, Unexpected (2099); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Age/date of birth: unknown/ not provided.Date of event: unknown, not provided.Best estimate was (b)(6) 2020 to (b)(6) 2020.If explanted, give date: unknown/not provided.(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that a doctor had to exchange one toric intraocular lens for another.This was due to lens rotated, and it was replaced with a model zcu300 22.5 diopter lens, because he was slightly plus.It was also noted that the exchange went well with no patient complications.
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Manufacturer Narrative
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Device evaluation: product evaluation was not performed because the product has not been returned.If product is received after initial closure, the investigation request (ir) and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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