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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown, not provided.If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted.Telephone number: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that a model pcb00 preloaded intraocular lens (iol) was already defective when it came out of the packaging and could not be used for surgery.Additional information received through follow-up reported that the haptic came out twisted after pushing the lens forward.The site is unsure if the lens was defective itself or the damage occurred during transportation.No further information available.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; section d9: date returned to manufacturer: 2nd august 2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the plunger was observed, in the advanced position.No assembly error and or defect related to manufacturing process was identified.Traces of lubricant material were observed, in the cartridge and in the lens storage zone.The lens got stuck at the cartridge tip, which is cracked/damaged.Leading haptic not folded condition was not identified.However, as the lens is too hard in the device, it is not possible to remove it to verify, the haptic damaged condition.Due to the condition of the sample returned product, quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search of complaints related to production order was performed.No additional complaint was received from this production order.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
• MDR Report Key: 12105847
• Report Number: 2648035-2021-07994
• Device Sequence Number: 4616033
• Product Code: HQL
• UDI-Device Identifier: 05050474558045
• UDI-Public: (01)05050474558045(17)240216
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 02/16/2024
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1