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

Model Number	ZCB00
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as there is an indication that the lens was remain implanted.Section d6b: if explanted, give date: not applicable 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Show less.
Event or Problem Description
It was reported that the surgeon pulled some particle out of a patient's eye from the injector after injecting iol.Additional information revealed that when implanting the lens, there was an additional sharp piece that came out with it.It almost looked like this was a shredded piece of the internal cartridge that got formed as the metal plunger was pushing the lens into the eye.It happened as it injected the lens into the eye.It occurred because the metal plunger may have scraped the internal underside of the cartridge and ripped a piece off, which was subsequently implanted in the eye.The implanted piece created an iris defect during removal.That patient is currently implanted with that iol and has some postoperative blood, some glare, and discomfort, but is doing ok.No surgical and medical interventions are required.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: no.Section d9: device date returned to manufacturer: not returned.Section h3: device evaluated by manufacturer: yes, photo was evaluated.Device evaluation: no suspect product was received; however, photos were provided by the customer.The customer provided photos were evaluated.The photos display a specimen cup with an observed unknown particle and an unknown fluid.The complaint issue was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order was performed.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it is identified that this event is not reportable as the initially reported lens (model zcb00 with sn (b)(6)) had no allegation or deficiency reported against the lens and there was no report of medical or surgical intervention.Hence, the information from the initial mdr pertaining to the earlier mentioned codes and reportability (section b1 and b2) are no longer applicable and case is considered as not reportable.There will no longer be any further reporting under mfr report number 3012236936-2024-0001258.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: 19317497
• Report Number: 3012236936-2024-000125
• Device Sequence Number: 12677333
• Product Code: HQL
• UDI-Device Identifier: 05050474531871
• UDI-Public: (01)05050474531871(17)271022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000280
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 05/18/2024; 07/02/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/23/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2023
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Race: White