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

Model Number DFR00V

Device Problems Break (1069); Ejection Problem (4009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4, and a5: unknown; requested but not provided.Section b3: date of event: unknown; requested but not provided.The best estimate date is prior to (b)(6) 2024.Section d4: model number: unknown; requested but not provided.Section d4: serial number: unknown; requested but not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section h3 - other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that three johnson and johnson intraocular lenses (iols) did not work right.No further information was provided.This report is to capture the first lens event.Separate reports will be submitted to capture the second and third lens event.

Manufacturer Narrative

Additional information: through follow-up, it was reported that the preloaded intraocular lens (iol) would not deploy correctly and insert.The lens was partially inserted into the patient's left eye and then removed and replaced.Event date was sep 14, 2023.Directions for use was followed.There was a 10-minute delay in procedure.No incision enlargement, vitrectomy, or suture was required.The device model and serial number, patient gender, date of birth and age, race, weight, and the surgeon¿s name and phone number were also provided.No further information was provided.Correction: based on the additional information received, there is no indication that the lens was damaged, as initially reported (therefore, section h6: medical device problem code 1069 ¿ break, is no longer applicable); the additional information reported that the lens did not deploy correctly and was only partially inserted.Therefore, this event is assessed as not reportable.There will no longer be any further reporting under mfr report number 3012236936-2024-00490.Based on the additional information received, multiple fields are being corrected from what was reported on the initial report.Therefore, this supplemental report is capturing this new and corrected information.The following fields have been updated/corrected accordingly: section a2: date of birth: (b)(6) 1947.Section a2: age: 76 years.Section a3: gender: female.Section a4: patient weight: 185 pounds.Section a5: race: white.Section b3: date of event: sep 14, 2023.Section d1: brand name: tecnis iol.Section d2: common device name: lens, multifocal intraocular.Section d2: device product code: mfk section d4: model number: dfr00v.Section d4: catalog number: dfr00vu190.Section d4: serial number: (b)(4).Section d4: expiration date: jul 1, 2024.Section d4: unique identifier (udi) number: (b)(4).Section d6a: if implanted, give date: not applicable, as lens was not fully implanted.Section d6b: if explanted, give date: not applicable, as lens was not fully implanted.Section e1: first name: (b)(6).Section e2: health professional?: yes section e3: occupation: physician.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 and complaint history for production order for this device will be performed.Section h4: device manufacture date: jul 1, 2021.Section h6: medical device problem code 4009 - ejection problem.Section h6: health effect - impact code 4632 - prolonged surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: 18784675
• MDR Text Key: 337305569
• Report Number: 3012236936-2024-00490
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White