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

Model Number	AR40M
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information unavailable.Section a-4 patient weight: unknown/asked information unavailable.Section a-5 patient ethnicity: african american was provided.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure, therefore not explanted.Section h-3 device evaluated by manufacturer: the device 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 report will be filed.Section h-6 health effect - clinical code: 4581 incision enlargement section h-6 health effect - impact code: 4625 incision enlargement and sutures attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
After the ar40m model intraocular lens (iol) was inserted into the surgical site, the iol was unable to unfold completely.A new implant was successfully loaded and inserted into the patient¿s ocular sinister (left eye).The incision was enlarged and unplanned sutures were required.There was no serious patient injury and no vitrectomy.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 02-jul-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: a lens half was received in the original lens case which was in the original folding carton.The lens was inspected under magnification.The complaint lens was received cut in half and one half was missing.No further issues that would have caused or contributed to the complaint event were identified.Complaint issue "unfolding issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction 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: 19620376
• Report Number: 3012236936-2024-000180
• Device Sequence Number: 18264273
• Product Code: HQL
• UDI-Device Identifier: 05050474501782
• UDI-Public: (01)05050474501782(17)271213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: AR40M
• Device Catalogue Number: AR40MN0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: EMERALD CARTRIDGE LOT NO.: UNKNOWN
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Black Or African American