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	Capsular Bag Tear (2639)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b, gender: information unknown/not provided.Section d6a, if implanted, give date: not applicable.The iol was partially inserted therefore, not implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Therefore, not explanted.Section h3, device evaluated by manufacturer: the device has not been 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.Section h6- health effect - impact code: 4625 is being used to capture sutures.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) came out too fast.The injector is behind so it came out a bit.The lens was partially inserted into the right eye.The patient¿s capsule broke and sutures were used.Using sutures is not the doctor¿s standard practice but they were used as precautionary measure.No vitrectomy was required.The procedure was completed with an iol of the same model and diopter.No further information was provided.

• 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: 19543254
• Report Number: 3012236936-2024-000165
• Device Sequence Number: 7704943
• Product Code: HQL
• UDI-Device Identifier: 05050474502147
• UDI-Public: (01)05050474502147(17)280605
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 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: 06/12/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White