MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELITA; POWERED LASER SURGICAL INSTRUMENT

Model Number	EL2022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Blurred Vision (2137)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2-date of birth: unknown, information not provided.Section a3b, a4, and a5: unknown, information not provided.Section d4: model number, serial number: unknown, information not provided.Section d6a: if implanted, give date: not applicable as this is not an implantable device.Section d6b: if explanted, give date: not applicable as this is not an implantable device.Section e1: phone number: (b)(6).Section h3: other 81: product evaluation was not performed because the product has not been received.If product is received after initial closure, the product investigation (pi) and complaint (cp) (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and further escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after one month post-op, the patient was having cornea haze with foggy vision and low contrast visual acuity (va) in white background.The patient's pre-op best corrected visual acuity (bcva) was -3.75 d (6/6) and the prescribed plan was -4.5 d for the left (os) eye.There was no patient injury.The directions for use were followed.The patient was prescribed artificial tears, steroids, non-steroidal anti-inflammatory drugs (nsaids), and betamethasone sodium phosphate neomycin (sulfate).No further information is available.

• Brand Name: ELITA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20429856
• Report Number: 3012236936-2024-000275
• Device Sequence Number: 8420621
• Product Code: GEX
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K063682
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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
• Device Model Number: EL2022
• Device Catalogue Number: 0155-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Race: Asian