MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IFS FEMTOSECOND LASER

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Corneal Perforation (1792); Eye Injury (1845); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: information unknown / not provided.Gender: information unknown / not provided.Date of event: exact dates not provided.Model number: the model number is unknown, as the serial number was not provided.It was indicated to be a intralase femtosecond laser.Serial number: unknown, information not provided.Catalog number: a complete catalog number is unknown as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Udi number: udi number is unknown, as the serial number was not provided.Telephone number: information unknown / not provided.Device manufacture date: unknown, as the serial number was not provided.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The following article was received based on a literature review: article: comparison of the effects of femtosecond laser energy on corneal endothelium at two different dissection levels in femtosecond laser-assisted deep anterior lamellar keratoplasty for keratoconus.A prospective double armed interventional study was done to compare the endothelial safety of femtosecond laser (fsl) energy at two different dissection depths in fsl assisted deep anterior lamellar keratoplasty (fsdalk) for keratoconus.Twenty-five eyes of twenty-one patients with advanced keratoconus underwent fsdalk using the big bubble technique.Fsl was used to create lamellar cuts aiming for a residual stromal thickness of 110 um in group i (n = 11) and 80 um in group ii (n = 14), all of which were anterior to the descemet¿s membrane (dm) at the thinnest location.The 150 khz intralase ifs (johnson & johnson inc.) was used to cut the recipient cornea.Most of the endothelial cell loss occurred during the first 3 months after surgery in both groups; the 12-month post-operative endothelial cell density loss was 17.46% and 12.91% in groups i and ii, respectively.Two patients experienced dm microperforations during surgery; one occurred in each group, but they did not convert to penetrating keratoplasty (pk).Five patients had a double anterior chamber (ac) during their first postoperative visit; they were all successfully managed by ac rebubbling on the same day.There are no indications in the article of any interventions provided for endothelial cell loss and microperforations.A copy of the article is provided with this report.

• Brand Name: IFS FEMTOSECOND LASER
• Common Device Name: IFS FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11831729
• Report Number: 3006695864-2021-07727
• Device Sequence Number: 10822061
• Product Code: GEX
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K141852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention