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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity/race: unknown, information not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted if explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that post capsulary tear was noticed after insertion of a zcb00 model intraocular lens(iol) in the patient's right eye.Also it was mentioned that lens went bloop all of a sudden.Additional details received confirms that the lens was only partially inserted and as the lens was being inserted, surgeon identified a manufacturer defect, said that the lens was deformed and that the post capsulary tear was unrelated to this incident and was due to patient anatomy.Procedure was completed successfully using a non johnson and johnson surgical vision lens.No sutures or any medical/ surgical interventions were required.Patient was doing good and stable at the time of discharge.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 8/25/2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed the lens was received inside a jnj coated cartridge tip and had viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during loading.The lens was removed from the cartridge tip and cleaned; a cosmetic issue (scratch) was observed on the optic body.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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
• MDR Report Key: 12298506
• Report Number: 2648035-2021-08271
• Device Sequence Number: 14244316
• Product Code: HQL
• UDI-Device Identifier: 05050474531703
• UDI-Public: (01)05050474531703(17)241210
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: 12/10/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLATINUM LOT NUMBER: CJ19354
• Patient Weight: 116