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

Model Number	DXW300
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
Additional Manufacturer Narrative
Section a2, date of birth: unknown/not provided.Section a3b, a4, a5, and a6, patient information: unknown/not provided.Section b3, date of event: the customer said, ¿post operatively¿.Section d6b, if explanted, give date: unknown, the best estimate is prior to (b)(6) when we were notified the product was received by the johnson and johnson investigation site.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a johnson and johnson (jnj) intraocular lens (iol) was implanted in the patients both right and left eye.The directions for use were followed.During a post-operative examination, the patient reported glare and halos.As of june 20, 2024, the patient's outcome was reported as fully recovered.However, it was also reported that the patient is scheduled for an explant.The explant for both eyes subsequently occurred.The serial numbers were provided but the eye was not specified.No further information was provided.Note, the mdr for serial # (b)(6) is captured in manufacturer report number 3012236936-2024-0002362.The other eye serial #: (b)(6) is captured in manufacturer report number 3012236936-2024-0002363.
Additional Manufacturer Narrative
Section h3: evaluated by manufacturer: yes.Device evaluation: two specimen containers were received.One marked on the cap with a "l" and the other marked with a "r".Two lenses were received.The complaint did not specify which was associated with this event so both were evaluated in this complaint.The lens marked "l" presented cut in half.The lens was cleaned and no further issues were identified.The lens marked "r" was received cut in half which included a haptic that was cut and was missing.No further issues could be identified.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 drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20057991
• Report Number: 3012236936-2024-000236
• Device Sequence Number: 20743163
• Product Code: HQL
• UDI-Device Identifier: 05050474765337
• UDI-Public: (01)05050474765337(17)260822
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 08/22/2026
• Device Model Number: DXW300
• Device Catalogue Number: DXW300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male