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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/weight/ethnicity: unknown, not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model ar40mn intraocular lens (iol) was fully inserted in the patient's operative eye, when the surgeon noticed a haptic broken.The iol was removed and replaced with a back-up lens of the same model and diopter.There was no surgical or medical intervention required.The patient is reported to be doing ok post-op.No other information was available.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: 6/7/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the original folding carton, patient stickers, and directions for use (dfu) were received as well.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.Which is consistent with a lens that was handled, during removal and replacement.Lens damage (bent) was also observed, but can be attributed to handling.And returning the lens crushed in the lens insert and cannot be confirmed, to be related to manufacturing.The complaint issue could not be confirmed.And therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that the product was manufactured and released according to specifications.A search revealed, that no other complaints were received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.And the reported issue could not be verified.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
• MDR Report Key: 11734427
• Report Number: 2648035-2021-07695
• Device Sequence Number: 14411076
• Product Code: HQL
• UDI-Device Identifier: 05050474501782
• UDI-Public: (01)05050474501782(17)251123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2021

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: 11/23/2025
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT# UNKNOWN