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

Model Number	PCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intraocular lens (iol) had fibers on it when implanted in the patient's left eye.3 little strips of fiber.Doctor was able to remove them and left the lens implanted.Doctor very concerned.Doctor had to flip iol sideways and fibers seemed to be on the back side of the lens.No planned additional intervention.Patient doing fine post-op.Further follow-up confirmed that there were three very thin fibers stuck to the posterior aspect of the iol.All 3 seemed to be stuck together at the base of the attachment to the lens but fraying apart from each other.The doctor noticed it after he implanted the iol into the lens capsule.Doctor was able to lift up the iol with i&a hand piece and go behind the lens and aspirate it without tearing the capsule.Doctor can¿t really say if it had any color as it blended in really well but it definitely was not black or any other obvious color like red or green.The fibers are not returning to us as well as they were aspirated by the handpiece.
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.The device was not returned for evaluation as lens remains implanted; 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.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the following field has been updated accordingly: section g4: combination product: no.Section d9.Device available for evaluation? yes returned to manufacturer on: mar.14, 2023.Section h3.Device evaluated manufacturer? yes device evaluation: no complaint lens or alleged foreign material was returned for evaluation.The complaint issue reported could not be verified and no product deficiency could be identified.Visual inspection on the complaint handpiece was performed, and no defects or assembly issues were observed on the returned handpiece before and after disassembly for evaluation.The complaint issue ¿dc-foreign material - loose¿ was not confirmed.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.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: 16208013
• Report Number: 3012236936-2023-00127
• Device Sequence Number: 5382638
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)230123
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 03/31/2023

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: 01/23/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White