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

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown/ asked but not available.Section b3: date of event: unknown, not provided.Section d4: model number: a complete model number was not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as serial number was not provided.Section d4: unique device identifier (udi #): unknown, as serial number was not provided.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: initial reporter: address and telephone number: unknown, information not provided.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 h4: device manufacture date: unknown as serial number was not provided.Attempts have been made to obtain additional information regarding the complaint; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It is reported that doctor had explanted intraocular lens (iol).No further information is available.
Additional Manufacturer Narrative
Correction: h6 - type of investigation, investigation findings and investigation conclusion updated.In follow up #1 it was stated investigation was in progress however, it was completed.The manufacturing records review for the device shows that the units were released within specification.Device was not returned therefore, product evaluation could not be performed.Based on the limited information provided, it is not possible to determine an indication of product malfunction or product deficiency.
Additional Manufacturer Narrative
Below details are updated based on the additional information received on 07/28/2023: section d1: brand name: tecnis iol,lens section d2: common device name: lens, intraocular, toric optics; device product code: mgp section d4: model number: diu150, catalog number: diu150u195, serial number:(b)(4), expiration date: mar 11, 2026, unique identifier (udi) number: (b)(4).Section h4: device manufacture date: mar 11, 2023.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: 17263353
• Report Number: 3012236936-2023-01712
• Device Sequence Number: 5885429
• Product Code: HQL
• UDI-Device Identifier: 05050474746534
• UDI-Public: (01)05050474746534(17)260311
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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 Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 03/11/2026
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U195
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 08/21/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/21/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2023
• 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 Sex: Unknown