MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a vitrectomy while using a sensar 3-piece acrylic monofocal intraocular lens (iol) on patient's left eye (os) oculus sinister.No further information provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown, as information was requested and was not provided.Section d6a: if implanted, give date: not applicable, as information was not provided.Section d6b: if explanted, give date: not applicable, as information was not provided.Section h3-other (81): the intraocular lens (iol) was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional information: historical data analysis: a search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.Corrected data: in review, it was noticed that section "a6" inadvertently was not addressed in the section "h11" of the initial mdr report.Also, it was realized that the verbiage for section d6a and d6b require an update; therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21069116
• Report Number: 3012236936-2025-000002
• Device Sequence Number: 11636217
• Product Code: HQL
• UDI-Device Identifier: 05050474502147
• UDI-Public: (01)05050474502147(17)281116
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: AR40E
• Device Catalogue Number: AR40E00220
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female