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

Model Number	SCP680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Telephone number - (b)(6).J&j representative spoke with the account.The account reported that patient had zonular fragility (intrinsic condition of the high-myopic patient).The j&j representative reported that this had nothing to do with the surgeon's skill or inefficiency of the intuitive equipment and that such a circumstance could not have been avoided and could have occurred using any equipment on the market.Manufacturing records review: the manufacturing records for the device were reviewed.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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an anterior vitrectomy was necessary due to rupture of the posterior lens capsule during cataract surgery using the phacoemulsification technique.This was using the compact intuitive system and a vitrectomy probe which didn't work therefore, patient was transferred to another clinic to complete the procedure.No additional information was provided.This report is for the compact intuitive system.Refer to 3012236936-2022-01674 for the report for the vitrectomy cutter.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code 4632 was not provided on the initial report.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: 14795273
• Report Number: 3012236936-2022-01675
• Device Sequence Number: 5050519
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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?: 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: 05/30/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: VITREOUS CUTTER LOT# 60289909
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown