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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter name: telephone number: (b)(6).The device was not returned for evaluation as it was discarded; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation, the surgeon was unable to advance intraocular lens (iol) as it was difficult to advance.Iol was managed to be implanted into the eye, however, the haptic was observed broken.Iol was removed and replaced.No adverse effect to the patient.Product was discarded.No further information available.
Additional Manufacturer Narrative
Corrected data: additional information was provided and reported that after the haptic loop broke, it did not affect the optical surface of the iol, therefore, the surgeon did not remove the iol.Iol remains implanted.The patient has no abnormal condition.This supplemental filing is to correct the comment that the iol was removed and replaced.The following sections have been updated accordingly: section d6a: if implanted; give date: (b)(6) 2022 section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section h6: health effect - impact code: removed 4631 more complex surgery and replaced with 2199 no health consequences or impact.Section h6: type of investigation: removed 4115 and replaced with 4117 device not accessible for testing.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: 14691407
• Report Number: 3012236936-2022-01577
• Device Sequence Number: 15126504
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)241118
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Patient Sex: Unknown