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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that non preloaded intraocular lens implanted a 3.0 diopter on 12-6-23.Upon delivery in the eye, surgeon noticed the haptics were bent and she explanted that lens.A second iol was loaded but she noticed that the haptics were bent as well.This second iol had not patient contact.A third iol, ar40e 3-piece, was loaded and successfully implanted.The incision was enlarged but only to accommodate the 2.85 incision needed for the ar40e versus the 2.4mm phaco incision.The patient was fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/ asked but not available.Section d6a: if implanted; give date: n/a.The intraocular lens was inserted and removed during the same procedure.Section d6b: if explanted; give date: n/a.The intraocular lens was inserted and removed during the same procedure.Additional information: jnj sales representative was contacted during the event and he instructed the account not to reload or use the second iol (with bent haptics).He guided them on properly loading another ar40e 3-piece iol and the account also brought a more experienced tech into the room for that loading.The 3rd ar40e 3.0 diopter lens was successfully implanted.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.Attempts have been made to obtain missing information; however, to date, no response has been received.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: 18385043
• Report Number: 3012236936-2023-03254
• Device Sequence Number: 2699451
• Product Code: HQL
• UDI-Device Identifier: 05050474501850
• UDI-Public: (01)05050474501850(17)280128
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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 Model Number: AR40E
• Device Catalogue Number: AR40E00030
• 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: 12/06/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2023
• 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
• Patient Sex: Unknown