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

Model Number	AAB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the aab00 18.0 diopter intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye) after cataract surgery.Patient reports she is having visual issues.She has severe photopsia and said she sees multiple circles and when she drives, the light is blinding and she cannot see at all.This is when she is watching tv, cell phone, and when driving, it occurs at daybreak and dusk.Patient has spoken to her doctor and he prescribed prednisone drops that are not helping.She seems to think she has the same lens in both eyes.Patient is scheduled to see her doctor on (b)(6) 2023.No further information is available.
Additional Manufacturer Narrative
Additional information: date of event: unknown/asked but unavailable.Date explanted: not applicable as the iol remains implanted.Device evaluated by mfr: it was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s ocular sinister.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record and historical data analysis 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.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.
Additional Manufacturer Narrative
Additional info: additional information was received from the customer stating she is currently still having halos and glare and she sees flashes at night.When the sun comes down she is blinded by the sun.She sees yellow and green circles.No further information is available.The following section has been updated accordingly: section h-6 health effect - clinical code: 2140, added to capture glare-persistent.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: 16266249
• Report Number: 3012236936-2023-00182
• Device Sequence Number: 19877210
• Product Code: HQL
• UDI-Device Identifier: 05050474548626
• UDI-Public: (01)05050474548626(17)260220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2026
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White