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Section a2, a3, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: date unknown, as information was requested but not provided section d6a - implant date: unknown, as information was requested but not provided.Section d6b - explant date: n/a - as lens remains implanted.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed because the product was not returned (the lens remains implanted).Therefore, a failure analysis of the complaint device cannot be completed, and the reported event cannot be confirmed.Photographs provided by the customer were evaluated.The photographs displayed the suspect product patient sticker label and a screenshot of a label scan result.The screenshot showed the correct serial number but an incorrect diopter.The photograph of the label was printed and the barcode was scanned resulting in the output: (b)(6).The first and last original folding carton label barcode for the production order was scanned from the traveler production order (po) resulting in the output: dcb0000130 (b)(6) and dcb0000130 (b)(6).These scans displayed the correct diopter power.The patient sticker barcodes could not be scanned.Per manufacturing, to confirm the diopter, the barcode from the folding carton or the patient sticker affixed to the implant notification card is required.However, no additional photographs or labels were received.Therefore, the complaint issue could not be confirmed.The complaint issue "labeling issues" was not identified during photograph evaluation.Therefore, there is no indication of a product deficiency or product malfunction.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this po was performed.The search revealed that no additional complaints were received.No escalation required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported by the customer that there were two incidents involving the incorrect scanning of intraocular lens (iol) implants.On (b)(6) 2025, it was noted that the serial numbers for the lenses were correct; however, the scanned information indicated different powers than what was actually used.Specifically, a 13.0d lens was scanned as a 21.5d lens, and an 11.5d lens was also incorrectly logged.This discrepancy was not caught by the circulating practitioner or the surgeon, leading to potential issues with patient records and future procedures.Fortunately, the correct lenses were implanted in both cases, and no patients were harmed.The staff has been alerted to be more vigilant during the scanning process to prevent similar occurrences in the future.No further information was provided.A total of two cases were reported.The second case has been captured in a separate file.
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