Model Number DIB00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Blurred Vision (2137); Visual Disturbances (2140)
|
Event Date 12/22/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Unknown/ asked but unavailable.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could cause or contribute to visual disturbances were identified.Based on the return condition of the lens, no further product evaluation could be performed.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.An attempt was made to obtain missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported the dib00 16.0 diopter intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Patient reports complaints of difficulty seeing to read street signs and night driving.Post-operatively, os vision is only correcting to 20/30-2 as of (b)(6) 2022.An iol explant was planned for a later date with another dib00, diopter unknown, as the replacement lens.No patient injury reported.Additional information received indicated that the lens was explanted on (b)(6) 2022.The patient outcome was not provided.No further information was received.
|
|
Manufacturer Narrative
|
Upon further review, it was noted that section g-3 date received by manufacturer, 07-nov-2022, reported in the initial mdr was incorrect.The following information was updated from 07-nov-2022 to 09-dec-2022.In addition, section h6-type of investigation was updated to include code 3331: analysis of production records and code 4109: historical data analysis as this information was not included in the initial report.The following fields were updated accordingly: section g-3 date received by manufacturer: 09-dec-2022.Section h6-type of investigation: 3331.Section h6-type of investigation: 4109.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Search Alerts/Recalls
|
|