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

Model Number SCP680300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Visual Impairment (2138); Eye Burn (2523)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

Pt info: unknown/ not provided.Establishment name: unknown/not provided.Initial reporter telephone number: (b)(6).Device evaluation: a field service specialist visited the account and was able to complete a system service checklist.System met johnson & johnson surgical vision (jjsv) specifications.No problem found with system.Successfully completed prime tune for 2 units of hand piece owned by user without any error.Manufacturing record review: a record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, lot history, and trending were reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.The review of the device history record (dhr) for the patient interface showed that there were no issues or non-conformities.The device and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a corneal wound burn occurred during cataract surgery.There was some damage to the endothelium (inside of the cornea).Sutures were required and surgery was completed.At present vision is quite poor.No further information available.

• Brand Name: COMPACT INTUITIV
• Type of Device: 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: 12849500
• MDR Text Key: 281068839
• Report Number: 3012236936-2021-00026
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K133115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female