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

Model Number	ZA9003
Medical Device Problem Codes	Inaccurate Delivery (2339); Ejection Problem (4009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: patient weight: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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.Section h6- health effect - clinical code 4581: no code available (incision enlarged & vitrectomy).Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) backed out of the womb.The issue was noticed when the lens was being partially inserted into the patient¿s right eye.There was an incision enlargement and a vitrectomy performed.The patient did not get a lens on this surgery day.The patient is recovering well.No further information was provided.The customer reported two incidents with the same eye of the patient; however, it is unknown which lens was attempted first.This emdr report is two (2) out of two (2).A separate report will be submitted for the other incident.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the narratives for the codes "h6- health effect - clinical code 4581 and h6: health effect - impact code: 4625" were inadvertently not properly addressed in the section h10 of the initial mdr report.Therefore, the information has been corrected in this supplemental mdr report as indicated below: section h6- health effect - clinical code 4581 - no code available (incision enlargement).Section h6: health effect - impact code: 4625 - incision enlargement & unplanned vitrectomy.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that an incorrect device code " 2339 - inaccurate delivery" was inadvertently entered in the section h6 of the initial mdr report instead of "4009 - ejection problem"; therefore, the information has been corrected in this supplemental mdr report and the following field was updated accordingly: section h6: medical device problem code: 4009 - ejection problem additional information: additional information received from customer indicated that the lens backed out of eye.That the patient was 58 years old and the cartridge was an emerald cartridge, lot cm08128.The following fields were updated accordingly: section a2: age: 58 years section d10: concomitant medical products: emerald cartridge, lot cm08128 section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jul 20, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue and with the haptic detached.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.The lens was evaluated further by johnson & johnson subject matter expert (sme).The lens drill holes were measured by sme.Both drill holes were observed to be within specification of the lens.The complaint issue "delivery issues" 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.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 17076118
• Report Number: 3012236936-2023-01405
• Device Sequence Number: 17852920
• Product Code: HQL
• UDI-Device Identifier: 05050474529052
• UDI-Public: (01)05050474529052(17)261205
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/15/2023

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: ZA9003
• Device Catalogue Number: ZA90030220
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 08/14/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/10/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD CARTRIDGE, LOT CM08128
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American