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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A6: account reported the patient race is asian/pacific islander - japanese, asian/pacific islander - korean.Health effect - clinical code 4581 used for incision enlargement health effect - impact code 4625 - additional surgery used for the unplanned vitrectomy, sutures and incision enlargement the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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.
Event or Problem Description
Account reported that patient had cataract procedure in which the intraocular lens (iol) was implanted.After iol was implanted the doctor noticed the haptic was kinked and he proceeded to remove the lens during the same procedure.The account indicated there was a capular tear and the patient had a vitrectomy, sutures and incision enlargement.The patient was left aphakic and the plan is to have a secondary lens at a later date.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the following codes (2199 & 4582) were inadvertently not entered in the section h6 of the initial mdr report.Also, in section "g2" the box for "user facility " was inadvertently not selected in the initial mdr report and the fields (d8 & d9) were either left empty or not correctly selected.The information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section g2: report source: user facility.Section d8: was this device serviced by a third party servicer?: no.Section d9: device available for evaluation? no.The following additional codes were added: section h6: health effect - impact code: 2199 - no health consequences or impact - this code was used to capture (incomplete treatment/ aphakic).Section h6: health effect - clinical code: 4582 - no clinical signs, symptoms or conditions - this code was used to capture (incomplete treatment/aphakic).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: 21999010
• Report Number: 3012236936-2025-000133
• Device Sequence Number: 18346684
• Product Code: HQL
• UDI-Device Identifier: 05050474502048
• UDI-Public: (01)05050474502048(17)290702
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00170
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander