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

Model Number	AR40E
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, a non-preloaded monofocal intraocular lens (iol) became lodged in the cartridge during insertion into the patient¿s left eye.The lens was partially inserted and subsequently removed during the same procedure, resulting in an approximate 20-minute delay.The condition of the lens, haptics, and cartridge tip remains unknown.The cartridge model and lot number were not reported.It is unknown whether increased resistance was encountered or if additional force was required during lens delivery.The event was noted to be unrelated to use error.The procedure was completed using a backup iol of the same model and diopter along with a backup cartridge.The procedure required unplanned incision enlargement, suturing, and vitrectomy.Information regarding the presence of a capsular tear necessitating vitrectomy, as well as the reason for or number of sutures placed, is unavailable.The patient recovered fully without impact to daily activities.No medical attention or medication outside of the standard of care was required.It was reported that the device did not cause or contribute to the event, and the directions for use were followed.No additional information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown, information was requested but not provided.Section d6a, if implanted, give date: not applicable as the iol was not implanted.Section d6b, if explanted, give date: not applicable as the iol was not implanted.Therefore, not explanted.Section h6: health effect - impact code: 4625 - additional surgery (incision enlargement, suture & unplanned vitrectomy).Section h6- health effect - clinical code 4581: no code available (incision enlarged).Attempts were made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d10: concomitant medical product: j&j cartridge, model/lot: unknown.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was partially stuck in the cartridge with viscoelastic residue observed throughout the cartridge.Stress marks were observed on the cartridge and the cartridge tip was deformed and damaged.The lens could not be removed from the cartridge; however, one haptic was observed to be bent.No further evaluation was performed.The complaint issue "delivery issue" was not identified during product evaluation.The observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 24722400
• Report Number: 3012236936-2026-000080
• Device Sequence Number: 21368618
• Product Code: HQL
• UDI-Device Identifier: 05050474502109
• UDI-Public: (01)05050474502109(17)291016
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J&J CARTRIDGE, MODEL/LOT: UNKNOWN.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White