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

Model Number	AAB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Scratched Material (3020); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as no indication that lens was implanted.Section d6b: if explanted, give date: not applicable, as no indication that lens was implanted, hence not explanted.Section e1: telephone number: (b)(6).Section h3-other (81): 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 will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) lens did not unfold at the time of implantation in the patient's left eye, and as a result, it became stuck in the incision.The doctor attempted to reposition it; however, during an inspection, he noticed that it was marked in the optical zone.It was necessary to use another lens that was available for the patient.The procedure was successfully completed using the back-up lens.Patient recovered, no harm to the patient.There was no postoperative injury.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: feb.29, 2024.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection of the complaint lens reveal that it was coated in viscoelastic residue.The lens was cleaned, and no cosmetic issues were observed.No issues that could cause or contribute to the complaint issue were identified.The complaint issues "unfolding issue", "delivery issue", and "cosmetic issues" were not identified during product evaluation.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the component code (4755) was inadvertently not entered in the section "h6" of the initial mdr report; therefore, the information has been captured in this supplemental mdr report and the following field was updated accordingly: section h6: component codes: 4755 - part/component/sub-assembly term not applicable 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: 18238051
• Report Number: 3012236936-2023-03048
• Device Sequence Number: 12508318
• Product Code: HQL
• UDI-Device Identifier: 05050474548732
• UDI-Public: (01)05050474548732(17)261202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2024

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: AAB00
• Device Catalogue Number: AAB0000235
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 04/28/2024; 05/09/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 04/29/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White