Model Number VICM5 12.6 |
Device Problems
Misfocusing (1401); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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A4 - unk a5 - unk a6 - unk h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
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Event Description
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The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6, -5.5 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The wrong post-operative correction for calcuation was use by surgeon by error.Lens remains implanted.Cause of the event is reported as user error.
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Manufacturer Narrative
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Corrected data: h6-health effect- clinical code: "2137" should be added.B5- the reporter indicated the surgeon implanted a 12.6mm vicm5_12.6implantable collamer lens of diopter -5.50 into the patient's left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.Reportedly "he used the wrong parameter for calculation." on (b)(6) 2023 the lens was exchanged with the same model, longer length lens and the problem was resolved.The reporter indicated the cause of the event is user error and the device did not fail to perform as intended.Cause details: "surgeon used the wrong postoperative correction for calculations".D6b.- (b)(6) 2023 should be added.H6-health effect- impact code: "2199" should be removed and "4629" should be added.H6- medical device problem code: "1401" amd "2993" should be added.Claim# (b)(4).
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Search Alerts/Recalls
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