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

Model Number	AR40E
Medical Device Problem Codes	Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during implantation the non-pre-loaded ar40e model intraocular lens (iol) was inserted into the patient¿s ocular sinister (left eye) and removed due to torn iol during the procedure.It was also mentioned only the cartridge tip contact had patient contact with patient's os.The iol was wasted because the tech loaded the lens into machine incorrectly.The incision was enlarged however there was no patient injury, no suture(s) and no vitrectomy.The replacement lens was another ar40e 4.0 diopter iol.Patient outcome was reported as fully recovered.The suspect iol is not available for return as it was destroyed.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient date of birth: unknown however both (b)(6)1919 and (b)(6) 1957 were provided.Sections a-4 patient weight: unknown/asked information unavailable.Section b-3: date of event: unknown however both (b)(6) 2023 and (b)(6) 2023 were provided.Section d-6a date implanted: not applicable as the iol was inserted and removed during the same procedure.Section d-6b date explanted: not applicable as the iol was inserted and removed during the same procedure, therefore not explanted.Section h3-81: the device was not returned for evaluation as it was discarded.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.

• 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: 17347337
• Report Number: 3012236936-2023-01849
• Device Sequence Number: 6068399
• Product Code: HQL
• UDI-Device Identifier: 05050474514065
• UDI-Public: (01)05050474514065(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/18/2023

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 Expiration Date: 04/30/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00025
• 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: 06/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White