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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information unknown/ not provided.Implant date: lens was not implanted explant date: lens was not implanted, therefor not explanted (b)(6).The intraocular lens (iol) has not yet been returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of an iol (intraocular lens), the doctor saw that a tear in the cartridge and one of the haptics wanted to get through.He stopped and removed the inserter together with the iol from the eye.A new lens and inserter were used instead.Through follow-up it was learned that the damage was at the cartridge tip section.No medical or surgical interventions were reported and no further details provided.This emdr report is for the first reported event.Separate reports will be submitted for the other two events.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 14th february 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received stuck inside of a cartridge crack that extended into the tip of the cartridge.The lens was also observed to be overridden by the plunger rod.The handpiece was disassembled and the assembly was inspected, presenting with no assembly issues.The lens was removed and cleaned, presenting with a detached haptic as well as scratches on the optic body.The complaint issue could be confirmed; however, it may be attributed to inadequate ovd usage during loading and insertion, and excessive force being applied to a stuck lens, suggested by the fact that the lens was stuck in the crack and that it was overridden by the plunger rod, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 13247661
• Report Number: 3012236936-2022-00130
• Device Sequence Number: 4711835
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)240621
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 06/21/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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