|
Model Number 1MTEC30 |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/22/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Lot#: unknown/not provided.Expiration date: unknown as product lot number was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Device manufacture date: unknown, as the lot number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|
|
Event Description
|
It was reported that the lens got stuck in the middle of the incision (left eye) so it was removed and another lens of the same model was used.There was no incision enlargement; however, one 10-0 nylon suture was used.There was no patient injury no additional information was provided to johnson and johnson surgical vision, inc.
|
|
Manufacturer Narrative
|
Device available for evaluation? yes.Returned to manufacturer on: 05/2/2018.Device returned to manufacturer? yes.Device evaluation: the product was received in open pouches of the original packaging and the original packaging label.Inspection was performed by a qualified inspector using a 12x magnification, and showed no abnormalities on the lens.No damages, or reject on the returned lens.Lens was further measured, and all measurements (haptic width, optic diameter, overall diameter and haptic thickness) were within specification.The complaint cannot be confirmed.Manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no other complaint was received from this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Manufacturer Narrative
|
Correction: in review of the mdr filings, it was noted that the supplemental mdr#1 (medwatch #(b)(4)) was filed in error on the lens; the concomitant product; not the cartridge as required.This supplemental mdr is being submitted on the cartridge to report the investigation results on the actual suspect device.Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing record review: the manufacturing record was not reviewed since the lot number is unknown.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency.The complaint cannot be confirmed all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
|
Search Alerts/Recalls
|
|
|