Model Number ZCT150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Blurred Vision (2137); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.However, there is a planned explant scheduled for (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that a zct150 21.5 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2017.Post-operatively, there was a surprise outcome with the astigmatic patient.There were several corneal measurements pre-operatively, which suggested a toric lens for the patient, but the patient had 1 - 1.5 diopters of cylinder in the opposite access.The patient's pre-operative visual acuity was 20/50 without correction and post-operatively vision was also 20/50 uncorrected.Visual acuity for both eyes pre-operatively were 20/20.Post-operatively, one week after surgery, the patient still complained of blurry vision and the manifest refraction had unexpected results.Pre-operative auto refraction results were +2.00 x -1.50 x 104 and post-operative refraction results were +0.75 x -1.50 x 10 with a best corrected visual acuity of 20/15.There is a planned explant scheduled for (b)(6) 2017 no additional information was provided.
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Manufacturer Narrative
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Additional information received indicated that the lens was not explanted.After consulting with j&j medical affairs, the account decided that the best course for the patient was a rotation of the original intraocular lens.It was confirmed that no incision enlargement, vitrectomy or sutures were required for the rotation and there was no patient injury at any time reported.The following has been updated accordingly: (b)(4).Device evaluation: the product testing was not performed as the complaint devices were not returned for evaluation (the lens remains implanted).The reported complaint cannot be verified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Historical data analysis: the search in complaint history revealed no similar complaints were received for this production order number.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.
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Search Alerts/Recalls
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