MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC COMPACT INTUITIV; UNIT, PHACOFRAGMENTATION

Model Number	SCP680300
Medical Device Problem Codes	Energy Output Problem (1431); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.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: email address: unknown/not provided, as information was asked but it was not provided.Section e1: telephone number: (b)(6).Device evaluation: field service engineer (fse) visited site to service the system and found the iv drip tubing (intrafix brand) they use not giving a good flow during continuous irrigation and test chamber collapse intermittently.Tested with another iv drip tubing (sangofix brand) and the flow is good and test chamber is stable.User was advised to use sangofix brand iv drip tubing.Hand piece voltage and vacuum measured in specifications.System is working well.Manufacturing records review: the manufacturing records for the device were reviewed.No nonconformity report, documentation or labeling changes, and escalations are required.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Use error may have caused/contributed to the reported event.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was corneal burn (thermal injury) on patient's left eye.No further information available.
Additional Manufacturer Narrative
It was identified on 06 nov 2023 that during field service in (b)(6), the phaco machine had irrigation flow issue during procedure and power issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: COMPACT INTUITIV
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 17722036
• Report Number: 3012236936-2023-02294
• Device Sequence Number: 17964204
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K133115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPO85
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female