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

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5 (race): unknown/ not provided.(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.Section h6: health effect clinical code: 4581 (to capture posterior capsule opacification).Attempts were made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony toric ii intraocular lens (iol) was explanted from the patient's right eye due to blurry vision.This was replaced with a tecnis eyhance toric ii iol, model diu225, but same diopter size as the original iol.No additional surgical interventions were indicated and no patient injury reported.It was noted that at.1 day post op visual acuity (va) 20/30-2.1 week post op va 20/40-1.1 month post op va 20/30-2, right eye (od).Manifest refraction (mrx) plano -1.00 115 20/20- 1 month post op left eye (os) - od va 20/30-2 os mrx +0.25 -1.00 115 20/20-1.Patient states that she is unhappy with starbursts around lights od mrx plamo -0.75 110 20/25+2 posterior capsule opacification (pco) check found to be minimal.Patient states that her starbursts and halos have been present daily.Va 20/40 od mrx +0.25 -0.25 116 20/30 patient still states that starburst and halos are present.Unable to neuroadapt after > 6 months.Plan for iol exchange.Va 20/25-3 od mrx plano plano 20/25-3.It was noted that the patient was seen for 1 day post explant on 11/21/23 va 20/30-2.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: december 13, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection reveal that the lens was received cut in half.No issues that could contribute to the complaint event were identified.The complaint issues were not identified during product evaluation.Therefore, there is no indication of a product deficiency or product malfunction.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 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: TECNIS 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 dr.; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18341522
• Report Number: 3012236936-2023-03050
• Device Sequence Number: 17820647
• Product Code: HQL
• UDI-Device Identifier: 05050474764163
• UDI-Public: (01)05050474764163(17)250602
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 06/02/2025
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U205
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic